The following data is part of a premarket notification filed by Clonetics Corp. with the FDA for Epipack.
Device ID | K880999 |
510k Number | K880999 |
Device Name: | EPIPACK |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | CLONETICS CORP. 9620 CHESAPEAKE DR. SUITE 206 San Diego, CA 92123 -1324 |
Contact | Michael C Luecke |
Correspondent | Michael C Luecke CLONETICS CORP. 9620 CHESAPEAKE DR. SUITE 206 San Diego, CA 92123 -1324 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-08 |
Decision Date | 1988-03-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EPIPACK 73611749 1435269 Dead/Cancelled |
CLONETICS CORPORATION 1986-07-28 |