The following data is part of a premarket notification filed by Theyfit with the FDA for Theyfit Male Condom.
| Device ID | K150072 |
| 510k Number | K150072 |
| Device Name: | TheyFit Male Condom |
| Classification | Condom |
| Applicant | THEYFIT 4140 TATE STREET Covington, GA 30014 |
| Contact | Michael Cecil |
| Correspondent | Penny Northcutt REGSOULTIONS, LLC 174 WATERCOLOR WAY SUITE 103-403 Santa Rosa Beach, FL 32459 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-14 |
| Decision Date | 2015-04-14 |
| Summary: | summary |