The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Extend Stability Date For Condom W/sperm Lubricant.
| Device ID | K902804 |
| 510k Number | K902804 |
| Device Name: | EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT |
| Classification | Condom |
| Applicant | OKAMOTO U.S.A., INC. JEFFREY N. GIBBS, SUITE 600 1120 VERMONT AVENUE, N.W. Washington, DC 20005 |
| Contact | & Gibbs |
| Correspondent | & Gibbs OKAMOTO U.S.A., INC. JEFFREY N. GIBBS, SUITE 600 1120 VERMONT AVENUE, N.W. Washington, DC 20005 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-08-13 |