The following data is part of a premarket notification filed by Kut-guard, Inc. with the FDA for Bandage Removal Strip.
Device ID | K895884 |
510k Number | K895884 |
Device Name: | BANDAGE REMOVAL STRIP |
Classification | Tape And Bandage, Adhesive |
Applicant | KUT-GUARD, INC. P.O. BOX 6402 Hollywood, FL 33081 |
Contact | Win Hirsch |
Correspondent | Win Hirsch KUT-GUARD, INC. P.O. BOX 6402 Hollywood, FL 33081 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-05 |
Decision Date | 1989-12-27 |