The following data is part of a premarket notification filed by Howard Medical Co. with the FDA for Sterile Gauze Sponge - Pick-ups 12ply (gs-412), Pick-ups 16ply (gs-416).
| Device ID | K962234 |
| 510k Number | K962234 |
| Device Name: | STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416) |
| Classification | Gauze/sponge, Internal |
| Applicant | HOWARD MEDICAL CO. 1690 NORTH ELSTON Chicago, IL 60622 |
| Contact | Ross Litton |
| Correspondent | Ross Litton HOWARD MEDICAL CO. 1690 NORTH ELSTON Chicago, IL 60622 |
| 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 | 1996-06-11 |
| Decision Date | 1996-06-28 |