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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 K964927
Device Name STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
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 Received12/09/1996
Decision Date 02/07/1997
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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