The following data is part of a premarket notification filed by Advantage Credit Services, Inc. with the FDA for 1x5yd,2x6yd,3x5yd,4x6yd,1/2/3x10yd Gauze.
| Device ID | K871002 |
| 510k Number | K871002 |
| Device Name: | 1X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZE |
| 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 | 1987-03-11 |
| Decision Date | 1987-03-31 |