The following data is part of a premarket notification filed by American White Cross, Inc. with the FDA for Non-adhera Adhesive Pad 3x4.
| Device ID | K853334 |
| 510k Number | K853334 |
| Device Name: | NON-ADHERA ADHESIVE PAD 3X4 |
| Classification | Dressing, Wound, Drug |
| Applicant | AMERICAN WHITE CROSS, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky AMERICAN WHITE CROSS, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-09 |
| Decision Date | 1985-08-21 |