The following data is part of a premarket notification filed by Chemence Medical Products Inc. with the FDA for Derma+flex Qs High Viscosity Tissue Adhesive Model: Qs70404.
| Device ID | K101276 |
| 510k Number | K101276 |
| Device Name: | DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CHEMENCE MEDICAL PRODUCTS INC. 185 BLUEGRASS VALLEY PARKWAY SUITE 100 Alpharetta, GA 30005 -2222 |
| Contact | Patricia Lehman |
| Correspondent | Patricia Lehman CHEMENCE MEDICAL PRODUCTS INC. 185 BLUEGRASS VALLEY PARKWAY SUITE 100 Alpharetta, GA 30005 -2222 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2010-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854137001184 | K101276 | 000 |
| 00854137001177 | K101276 | 000 |
| 00854137001160 | K101276 | 000 |