The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Seminal Fluid Collection Kit Ii.
| Device ID | K954791 |
| 510k Number | K954791 |
| Device Name: | SEMINAL FLUID COLLECTION KIT II |
| Classification | Condom |
| Applicant | APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Contact | Stefanie Bedard |
| Correspondent | Stefanie Bedard APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1996-01-05 |