The following data is part of a premarket notification filed by Medicult A/s with the FDA for Medi-cult Blastocyst Freezing & Thawing Packs, Internal Catalog Numbers (1012, 1015).
| Device ID | K991471 |
| 510k Number | K991471 |
| Device Name: | MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) |
| Classification | Media, Reproductive |
| Applicant | MEDICULT A/S P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi MEDICULT A/S P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-14 |
| Decision Date | 2000-05-09 |
| Summary: | summary |