The following data is part of a premarket notification filed by Kemi Labs, Inc. with the FDA for Kemi Labs - Adhesive Bandage Remover.
Device ID | K895293 |
510k Number | K895293 |
Device Name: | KEMI LABS - ADHESIVE BANDAGE REMOVER |
Classification | Solvent, Adhesive Tape |
Applicant | KEMI LABS, INC. 91 OAK BLUFF RD. MILFORD, CT 06460 |
Contact | TOM SNELL |
Correspondent | TOM SNELL KEMI LABS, INC. 91 OAK BLUFF RD. MILFORD, CT 06460 |
Product Code | KOX |
CFR Regulation Number | 878.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-25 |
Decision Date | 1990-02-09 |