The following data is part of a premarket notification filed by Qualtex, Inc. with the FDA for Laparotomy Sponge.
| Device ID | K780818 |
| 510k Number | K780818 |
| Device Name: | LAPAROTOMY SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | QUALTEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1978-05-17 |
| Decision Date | 1978-06-22 |