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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, truncal/orthosis, limb
510(k) Number K973031
Device Name STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
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 Number890.3490
Classification Product Code
MRI  
Subsequent Product Code
HWC  
Date Received08/14/1997
Decision Date 11/03/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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