The following data is part of a premarket notification filed by Schmid Laboratories, Inc. with the FDA for Condoms (ramses Extra, Sheik Elite And Koromex).
| Device ID | K874791 |
| 510k Number | K874791 |
| Device Name: | CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX) |
| Classification | Condom |
| Applicant | SCHMID LABORATORIES, INC. ROUTE 46 WEST Little Falls, NJ 07424 |
| Contact | Phyliss M Barber |
| Correspondent | Phyliss M Barber SCHMID LABORATORIES, INC. ROUTE 46 WEST Little Falls, NJ 07424 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-23 |
| Decision Date | 1988-04-12 |