The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmaclusive (tm).
Device ID | K872573 |
510k Number | K872573 |
Device Name: | PHARMACLUSIVE (TM) |
Classification | Dressing, Wound, Drug |
Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Contact | Karl A Posselt |
Correspondent | Karl A Posselt PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
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 | 1987-06-29 |
Decision Date | 1988-02-29 |