The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Sterile Absorbent Gauze Burn & Sound.
Device ID | K840745 |
510k Number | K840745 |
Device Name: | STERILE ABSORBENT GAUZE BURN & SOUND |
Classification | Dressing, Wound, Drug |
Applicant | CHESEBROUGH-POND'S U.S.A. CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
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 | 1984-02-22 |
Decision Date | 1984-04-23 |