The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Debrisan Absorbent Pad.
Device ID | K872453 |
510k Number | K872453 |
Device Name: | DEBRISAN ABSORBENT PAD |
Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
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 | KOZ |
CFR Regulation Number | 878.4018 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-23 |
Decision Date | 1988-01-14 |