The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Okamoto Studded Condom.
Device ID | K141256 |
510k Number | K141256 |
Device Name: | OKAMOTO STUDDED CONDOM |
Classification | Condom |
Applicant | OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
Contact | Joseph W Cormier, Jd, Phd |
Correspondent | Joseph W Cormier, Jd, Phd 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 | 2014-05-14 |
Decision Date | 2014-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00813356000385 | K141256 | 000 |