Hirata Sangyo Co. USA, Inc.
Mchenry, IL, US
Hirata Sangyo Co. USA, Inc. appears in FDA device records in Mchenry, IL. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Hirata Sangyo Co. USA, Inc. between 1982 and 1986. The busiest year on record is 1983, with 4. The most recent is 1986, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 1 |
| 1986 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K864106 | SR-MODEL 230 (MODIFICATION) | FRN | Substantially Equivalent | |
| K842289 | SR- MODEL 230 | FRN | Substantially Equivalent | |
| K833542 | SURGICAL INSTRUMENT | GEN | Substantially Equivalent | |
| K833541 | SURGICAL INSTRUMENT | GAD | Substantially Equivalent | |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | HTO | Substantially Equivalent | |
| K831583 | GP-303 | DXN | Substantially Equivalent | |
| K821989 | NON-STETHO 7, UM-15TP | DXN | Substantially Equivalent | |
| K822571 | SYRINGE PUMP | FRN | 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