Gac Intl., Inc.
Central Islip, NY, US
Gac Intl., Inc. appears in FDA device records in Central Islip, NY. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Gac Intl., Inc. between 1977 and 1999. The busiest year on record is 1992, with 4. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1985 | 2 |
| 1992 | 4 |
| 1993 | 2 |
| 1994 | 3 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981036 | SMARTBOND | DYH | Substantially Equivalent | |
| K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET | DYW | Substantially Equivalent | |
| K933542 | MESIAL LOOP BAR | ECO | Substantially Equivalent | |
| K932825 | MICROARCH GOLD BRACKET | EJF | Substantially Equivalent | |
| K932319 | ORTHODONTIC ELASTOMER | ECI | Substantially Equivalent | |
| K932025 | ION-IMPLANTED NEO SENTALLOY | EJF | Substantially Equivalent | |
| K920905 | BIOFORCE WIRE | DZC | Substantially Equivalent | |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | EJF | Substantially Equivalent | |
| K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | DZC | Substantially Equivalent | |
| K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | DZB | Substantially Equivalent | |
| K852179 | CERAMIC ORTHODONIT APPLIANCE | EJF | Substantially Equivalent | |
| K851055 | SENTINOL -ORTHODONTIC ARCH WIRE | DZC | Substantially Equivalent | |
| K771774 | NEW BASE FOR ORTHODONTIC APPLIANCES | EJF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain