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 |