The following data is part of a premarket notification filed by Advantage Credit Services, Inc. with the FDA for 18x36,36x36,18x72,24x72 Gauze Compress.
Device ID | K871005 |
510k Number | K871005 |
Device Name: | 18X36,36X36,18X72,24X72 GAUZE COMPRESS |
Classification | Gauze/sponge, Internal |
Applicant | ADVANTAGE CREDIT SERVICES, INC. P.O. BOX 768 Kansas City, MO 64141 |
Contact | Howard J Gerson |
Correspondent | Howard J Gerson ADVANTAGE CREDIT SERVICES, INC. P.O. BOX 768 Kansas City, MO 64141 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-13 |
Decision Date | 1987-03-31 |