The following data is part of a premarket notification filed by Pacific Andrology, Inc. with the FDA for Pureception Lower Phase, Pureception Upper Phase, Pureception With Hepes-buffered Ham's F-10 And Hsa.
| Device ID | K991381 |
| 510k Number | K991381 |
| Device Name: | PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA |
| Classification | Media, Reproductive |
| Applicant | PACIFIC ANDROLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland PACIFIC ANDROLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-09-24 |