The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Modified Labeling On Okamoto Harmony Condom.
| Device ID | K896339 |
| 510k Number | K896339 |
| Device Name: | MODIFIED LABELING ON OKAMOTO HARMONY CONDOM |
| Classification | Condom |
| Applicant | OKAMOTO U.S.A., INC. 1120 VERMONT AVE., N.W. SUITE 600 Washington, DC 20005 |
| Contact | Jeffrey N Gibbs |
| Correspondent | Jeffrey N Gibbs OKAMOTO U.S.A., INC. 1120 VERMONT AVE., N.W. SUITE 600 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 | 1989-11-03 |
| Decision Date | 1990-01-10 |