The following data is part of a premarket notification filed by Tag Medical Corp. with the FDA for The Grapplr And Grapplr Extender.
Device ID | K101616 |
510k Number | K101616 |
Device Name: | THE GRAPPLR AND GRAPPLR EXTENDER |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | TAG MEDICAL CORP. 291 Hillside Avenue Somerset, MA 02726 |
Contact | George J Hattub |
Correspondent | George J Hattub TAG MEDICAL CORP. 291 Hillside Avenue Somerset, MA 02726 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-09 |
Decision Date | 2011-01-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10818674025758 | K101616 | 000 |
10818674025741 | K101616 | 000 |
10818674025734 | K101616 | 000 |
10818674025727 | K101616 | 000 |
10818674025710 | K101616 | 000 |