The following data is part of a premarket notification filed by Genx Intl., Inc. with the FDA for Sperm Preparation Media.
| Device ID | K962816 |
| 510k Number | K962816 |
| Device Name: | SPERM PREPARATION MEDIA |
| Classification | Condom, Synthetic |
| Applicant | GENX INTL., INC. 339 BARTLETT DR. Madison, CT 06443 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi GENX INTL., INC. 339 BARTLETT DR. Madison, CT 06443 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-19 |
| Decision Date | 1996-11-26 |
| Summary: | summary |