The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Sperm Washing Medium, Modified Sperm Washing Medium.
| Device ID | K983588 |
| 510k Number | K983588 |
| Device Name: | SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM |
| Classification | Media, Reproductive |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Roberta L Johnson |
| Correspondent | Roberta L Johnson IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857515006245 | K983588 | 000 |
| 00857515006207 | K983588 | 000 |
| 00893727002897 | K983588 | 000 |
| 00893727002095 | K983588 | 000 |