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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K965111
Device Name STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
Applicant
R. THOMAS GROTZ, M.D., INC.
530 BUSH STREET, 10TH FLOOR
san francisco,  CA  94108
Applicant Contact r. thomas grotz
Correspondent
R. THOMAS GROTZ, M.D., INC.
530 BUSH STREET, 10TH FLOOR
san francisco,  CA  94108
Correspondent Contact r. thomas grotz
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/20/1996
Decision Date 02/18/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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