The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Cryotip.
| Device ID | K041562 |
| 510k Number | K041562 |
| Device Name: | CRYOTIP |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Wendell Lee |
| Correspondent | Wendell Lee IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-10 |
| Decision Date | 2004-08-09 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRYOTIP 78406405 3159941 Live/Registered |
FUJIFILM IRVINE SCIENTIFIC, INC. 2004-04-22 |