The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Sperm Capacitation Medium.
Device ID | K861188 |
510k Number | K861188 |
Device Name: | SPERM CAPACITATION MEDIUM |
Classification | Cap, Cervical |
Applicant | IRVINE SCIENTIFIC CHARLES H. NEWMAN 25283 CABOT ROAD, STE. 207 Laguna Hills, CA 92653 |
Contact | Newman Assoc. |
Correspondent | Newman Assoc. IRVINE SCIENTIFIC CHARLES H. NEWMAN 25283 CABOT ROAD, STE. 207 Laguna Hills, CA 92653 |
Product Code | HDR |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-31 |
Decision Date | 1987-01-06 |