The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Wet Dressing Saline-sterile.
Device ID | K844096 |
510k Number | K844096 |
Device Name: | WET DRESSING SALINE-STERILE |
Classification | Dressing, Wound, Drug |
Applicant | ABSORBENT COTTON CO., INC. P.O. BOX 268 368 FAIRVIEW AVENUE Hammonton, NJ 08037 |
Contact | Cutiright |
Correspondent | Cutiright ABSORBENT COTTON CO., INC. P.O. BOX 268 368 FAIRVIEW AVENUE Hammonton, NJ 08037 |
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 | 1984-10-23 |
Decision Date | 1984-11-19 |