The following data is part of a premarket notification filed by Primeline Medical Products, Inc. with the FDA for Primed Prime-plus Cotton Gauze Sponges.
| Device ID | K971075 |
| 510k Number | K971075 |
| Device Name: | PRIMED PRIME-PLUS COTTON GAUZE SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | PRIMELINE MEDICAL PRODUCTS, INC. 2235-27TH AVENUE, N.E. CALGARY Alberta, CA T2e 7m4 |
| Contact | Guy Plamondon |
| Correspondent | Guy Plamondon PRIMELINE MEDICAL PRODUCTS, INC. 2235-27TH AVENUE, N.E. CALGARY Alberta, CA T2e 7m4 |
| 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 | 1997-03-24 |
| Decision Date | 1997-06-22 |