The following data is part of a premarket notification filed by Okamoto U.s.a. Inc. with the FDA for Okamoto 002 Lubricated Polyurethane Male Condom.
Device ID | K203541 |
510k Number | K203541 |
Device Name: | Okamoto 002 Lubricated Polyurethane Male Condom |
Classification | Condom, Synthetic |
Applicant | Okamoto U.S.A. Inc. 18 King Street Stratford, CT 06615 |
Contact | Yu Tadano |
Correspondent | Jeff N. Gibbs Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street N.W. Suite 1200 Washington, DC 20005 |
Product Code | MOL |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-03 |
Decision Date | 2022-02-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
80022600999832 | K203541 | 000 |