The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Omni Prep Gel.
| Device ID | K933797 |
| 510k Number | K933797 |
| Device Name: | OMNI PREP GEL |
| Classification | Media, Electroconductive |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton M Cadwell |
| Correspondent | Carlton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-04 |
| Decision Date | 1994-05-17 |