The following data is part of a premarket notification filed by Okamoto U.s.a. Inc. with the FDA for Okamoto 002 Lubricated Polyurethane Male Condom.
| Device ID | K203541 |
| 510k Number | K203541 |
| Device Name: | Okamoto 002 Lubricated Polyurethane Male Condom |
| Classification | Condom, Synthetic |
| Applicant | Okamoto U.S.A. Inc. 18 King Street Stratford, CT 06615 |
| Contact | Yu Tadano |
| Correspondent | Jeff N. Gibbs Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street N.W. Suite 1200 Washington, DC 20005 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-03 |
| Decision Date | 2022-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80022600999832 | K203541 | 000 |