The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-pp-9, 16-pp-5.75.
| Device ID | K000915 |
| 510k Number | K000915 |
| Device Name: | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 |
| Classification | Labware, Assisted Reproduction |
| 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 | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-22 |
| Decision Date | 2000-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937014123 | K000915 | 000 |
| 20888937014116 | K000915 | 000 |
| 20888937014109 | K000915 | 000 |
| 20888937014093 | K000915 | 000 |
| 20888937014086 | K000915 | 000 |
| 20888937014079 | K000915 | 000 |
| 20888937014062 | K000915 | 000 |
| 50888937014056 | K000915 | 000 |