The following data is part of a premarket notification filed by Omni Mfg., Inc. with the FDA for Omnisorb Ii, Nonwoven Sponge, Sterile And Non.
| Device ID | K931610 |
| 510k Number | K931610 |
| Device Name: | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | OMNI MFG., INC. P.O. BOX 1808 Eaton Park, FL 33840 |
| Contact | Mark J Lemko |
| Correspondent | Mark J Lemko OMNI MFG., INC. P.O. BOX 1808 Eaton Park, FL 33840 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-01 |
| Decision Date | 1993-06-24 |