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 |