The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Extremely Thin 003, Zero Zero Three.
| Device ID | K192669 |
| 510k Number | K192669 |
| Device Name: | Extremely Thin 003, ZERO ZERO THREE |
| Classification | Condom |
| Applicant | Okamoto U.S.A., Inc. 18 King Street Stratford, CT 06615 |
| Contact | Yu Tadano |
| Correspondent | Jeffrey N. Gibbs Hyman, Phelps & McNamara, P.C. Washington, DC 20005 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2020-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80022600200020 | K192669 | 000 |
| 80022600001535 | K192669 | 000 |