The following data is part of a premarket notification filed by Johnson & Johnson Consumer Companies, Inc. with the FDA for Freedom, Model 4660.
Device ID | K001023 |
510k Number | K001023 |
Device Name: | FREEDOM, MODEL 4660 |
Classification | Dressing, Wound, Drug |
Applicant | JOHNSON & JOHNSON CONSUMER COMPANIES, INC. 199 GRANDVIEW ROAD Skillman, NJ 08558 -9498 |
Contact | Joseph Kiceina |
Correspondent | Joseph Kiceina JOHNSON & JOHNSON CONSUMER COMPANIES, INC. 199 GRANDVIEW ROAD Skillman, NJ 08558 -9498 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-30 |
Decision Date | 2000-09-22 |