The following data is part of a premarket notification filed by Schmid Laboratories, Inc. with the FDA for Condoms (ramses, Sheik And Koromex).
| Device ID | K882893 |
| 510k Number | K882893 |
| Device Name: | CONDOMS (RAMSES, SHEIK 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 | 1988-07-11 |
| Decision Date | 1988-10-26 |