The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Dermiview Hypoallergenic Clear Tape.
Device ID | K944587 |
510k Number | K944587 |
Device Name: | DERMIVIEW HYPOALLERGENIC CLEAR TAPE |
Classification | Tape And Bandage, Adhesive |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
Contact | Ralph H Larsen |
Correspondent | Ralph H Larsen JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-19 |
Decision Date | 1995-10-30 |