The following data is part of a premarket notification filed by Theyfit with the FDA for Theyfit Male Condom.
| Device ID | K122219 |
| 510k Number | K122219 |
| Device Name: | THEYFIT MALE CONDOM |
| Classification | Condom |
| Applicant | THEYFIT 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt THEYFIT 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302340300435 | K122219 | 000 |