The following data is part of a premarket notification filed by Mark Sullivan, M.d., P.c. with the FDA for Condom Seal.
| Device ID | K903715 |
| 510k Number | K903715 |
| Device Name: | CONDOM SEAL |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | MARK SULLIVAN, M.D., P.C. 26732 CROWN VALLEY PKWY., SUITE 111 Mission Viejo, CA 92691 |
| Contact | Mark Sullivan |
| Correspondent | Mark Sullivan MARK SULLIVAN, M.D., P.C. 26732 CROWN VALLEY PKWY., SUITE 111 Mission Viejo, CA 92691 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1991-01-23 |