The following data is part of a premarket notification filed by American White Cross, Inc. with the FDA for Extra Large Adhesive Strips.
| Device ID | K852408 |
| 510k Number | K852408 |
| Device Name: | EXTRA LARGE ADHESIVE STRIPS |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-06 |
| Decision Date | 1985-07-29 |