The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Skinless Skin-harmony Condoms.
| Device ID | K872664 |
| 510k Number | K872664 |
| Device Name: | SKINLESS SKIN-HARMONY CONDOMS |
| Classification | Condom |
| Applicant | OKAMOTO U.S.A., INC. 18 KING ST. Stratford, CT 06615 |
| Contact | Naito |
| Correspondent | Naito OKAMOTO U.S.A., INC. 18 KING ST. Stratford, CT 06615 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-08 |
| Decision Date | 1987-11-05 |