The following data is part of a premarket notification filed by Schmid Laboratories, Inc. with the FDA for Male Condom.
| Device ID | K822088 |
| 510k Number | K822088 |
| Device Name: | MALE CONDOM |
| Classification | Condom |
| Applicant | SCHMID LABORATORIES, INC. HAMEL, PARK, MCCABE AND SAUDER 888 SIXTEENTH STREET, N.W. Washinton, DC 20006 |
| Contact | Wayne Matelski |
| Correspondent | Wayne Matelski SCHMID LABORATORIES, INC. HAMEL, PARK, MCCABE AND SAUDER 888 SIXTEENTH STREET, N.W. Washinton, DC 20006 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-13 |
| Decision Date | 1982-11-03 |