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 |