The following data is part of a premarket notification filed by Global Mailer Partners, Llc with the FDA for Jud Custom Fit Condom.
| Device ID | K172414 |
| 510k Number | K172414 |
| Device Name: | JUD Custom Fit Condom |
| Classification | Condom |
| Applicant | Global Mailer Partners, LLC 50 South Pointe Drive Miami Beach, FL 33139 |
| Contact | Jud Ireland |
| Correspondent | Adam Harris Target Health Inc. 261 Madison Avenue, 24th Floor New York, NY 10016 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2017-10-12 |
| Summary: | summary |