The following data is part of a premarket notification filed by Ortho Pharmaceutical Corp. with the FDA for Conceptrol/thin Prophylactics.
| Device ID | K792634 |
| 510k Number | K792634 |
| Device Name: | CONCEPTROL/THIN PROPHYLACTICS |
| Classification | Condom |
| Applicant | ORTHO PHARMACEUTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-19 |
| Decision Date | 1980-01-16 |