The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Endotine Transbleph 3.0/3.5 Device.
Device ID | K042796 |
510k Number | K042796 |
Device Name: | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE |
Classification | Screw, Fixation, Bone |
Applicant | COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94566 |
Contact | Bankim Mehta |
Correspondent | Bankim Mehta COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94566 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-07 |
Decision Date | 2004-11-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847399006806 | K042796 | 000 |
00847399006790 | K042796 | 000 |