The following data is part of a premarket notification filed by Chemence Medical Inc. with the FDA for Flex-aid Liquid Gel Bandage And Dermaflex Gel Tissue Adhesive Professional Liquid Bandage.
| Device ID | K050757 |
| 510k Number | K050757 |
| Device Name: | FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE |
| Classification | Bandage, Liquid |
| Applicant | CHEMENCE MEDICAL INC. 185 BLUEGRASS VALLEY PKWY. Alpharetta, GA 30005 -2222 |
| Contact | Scott Leal |
| Correspondent | Scott Leal CHEMENCE MEDICAL INC. 185 BLUEGRASS VALLEY PKWY. Alpharetta, GA 30005 -2222 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-23 |
| Decision Date | 2006-02-23 |
| Summary: | summary |