The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Extra Protection Polyurethane Condom.
| Device ID | K922688 |
| 510k Number | K922688 |
| Device Name: | EXTRA PROTECTION POLYURETHANE CONDOM |
| Classification | Condom, Synthetic |
| Applicant | APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Contact | Alice A Depaul |
| Correspondent | Alice A Depaul APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1995-05-04 |