The following data is part of a premarket notification filed by Johnson & Johnson Consumer Products, Inc. with the FDA for Parallel.
Device ID | K954007 |
510k Number | K954007 |
Device Name: | PARALLEL |
Classification | Tape And Bandage, Adhesive |
Applicant | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
Contact | Diana L. B Uhl |
Correspondent | Diana L. B Uhl JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-25 |
Decision Date | 1995-11-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00381370055709 | K954007 | 000 |
00381370055679 | K954007 | 000 |
00381371192533 | K954007 | 000 |