The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Okamoto Ultra Thin.
Device ID | K090259 |
510k Number | K090259 |
Device Name: | OKAMOTO ULTRA THIN |
Classification | Condom |
Applicant | OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
Contact | Jeffery N Gibbs |
Correspondent | Jeffery 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 | 2009-02-02 |
Decision Date | 2009-03-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00813356000354 | K090259 | 000 |
00813356000347 | K090259 | 000 |
00813356000330 | K090259 | 000 |
00850002174526 | K090259 | 000 |
00850002174519 | K090259 | 000 |
00850002174113 | K090259 | 000 |
00850002174106 | K090259 | 000 |
80022600001542 | K090259 | 000 |
80022600001573 | K090259 | 000 |