The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Intracytoplasmic Sperm Injection Micropipets (icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M.
| Device ID | K990847 |
| 510k Number | K990847 |
| Device Name: | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville, VA 22911 |
| Contact | Cindy Showalter |
| Correspondent | Cindy Showalter HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville, VA 22911 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-07-14 |
| Summary: | summary |