Chemence Medical Inc.
Alpharetta, GA, US
CHEMENCE MEDICAL INC. appears in FDA device records in Alpharetta, GA. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Chemence Medical Inc. between 2006 and 2021. The busiest year on record is 2020, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212246 | Exofin Precision Pen | MPN | Substantially Equivalent | |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | MPN | Substantially Equivalent | |
| K191461 | Exofin Fusion Skin Closure System | OMD | Substantially Equivalent | |
| K171442 | Exofin Fusion Skin Closure System | OMD | Substantially Equivalent | |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | MPN | Substantially Equivalent | |
| K050757 | FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE | KMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1067168 | 3002638508 | CHEMENCE MEDICAL INC. | 185 BLUEGRASS VALLEY PARKWAY, Alpharetta, GA 30005 US | 2026 | |
| 3010034760 | 3010034760 | CHEMENCE MEDICAL INC. | 200 Technology Dr, Alpharetta, GA 30005 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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