The following data is part of a premarket notification filed by Schmid Laboratories, Inc. with the FDA for Okamoto Condoms.
| Device ID | K880202 |
| 510k Number | K880202 |
| Device Name: | OKAMOTO CONDOMS |
| Classification | Condom |
| Applicant | SCHMID LABORATORIES, INC. WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski SCHMID LABORATORIES, INC. WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-19 |
| Decision Date | 1988-02-26 |