The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Cmc Cable Fix.
Device ID | K111032 |
510k Number | K111032 |
Device Name: | CMC CABLE FIX |
Classification | Washer, Bolt Nut |
Applicant | INSTRATEK, INC. 4141 DIRECTORS ROW SUITE H Houston, TX 77092 |
Contact | Jeff Seavey |
Correspondent | Jeff Seavey INSTRATEK, INC. 4141 DIRECTORS ROW SUITE H Houston, TX 77092 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-13 |
Decision Date | 2011-08-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327356441 | K111032 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CMC CABLE FIX 85324673 not registered Dead/Abandoned |
Intratek, Inc 2011-05-19 |