The following data is part of a premarket notification filed by American White Cross, Inc. with the FDA for Tricot Adhesive Bandage.
Device ID | K852462 |
510k Number | K852462 |
Device Name: | TRICOT ADHESIVE BANDAGE |
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 | 1985-06-10 |
Decision Date | 1985-07-26 |