The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Mega Big Boy Condom.
| Device ID | K140379 |
| 510k Number | K140379 |
| Device Name: | MEGA BIG BOY CONDOM |
| Classification | Condom |
| Applicant | OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Jeffrey N Gibbs |
| Correspondent | Jeffrey N Gibbs OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 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 | 2014-02-14 |
| Decision Date | 2014-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000439 | K140379 | 000 |
| 00850002174564 | K140379 | 000 |
| 00850002174557 | K140379 | 000 |