The following data is part of a premarket notification filed by Cornelia Damsky, Inc. with the FDA for Biostrip Sterile Wound Closure Strip.
| Device ID | K946321 |
| 510k Number | K946321 |
| Device Name: | BIOSTRIP STERILE WOUND CLOSURE STRIP |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | CORNELIA DAMSKY, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky CORNELIA DAMSKY, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-28 |
| Decision Date | 1995-01-12 |