The following data is part of a premarket notification filed by D.o. Weaver Co. with the FDA for Hydroprep Gel.
| Device ID | K964737 |
| 510k Number | K964737 |
| Device Name: | HYDROPREP GEL |
| Classification | Media, Electroconductive |
| Applicant | D.O. WEAVER CO. 565-C NUCLA WAY Aurora, CO 80011 |
| Contact | David O Weaver |
| Correspondent | David O Weaver D.O. WEAVER CO. 565-C NUCLA WAY Aurora, CO 80011 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-25 |
| Decision Date | 1997-03-19 |