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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, shoulder, hemi-, humeral, metallic uncemented
510(k) Number K911902
Device Name TEMPERLITE(TM) SAW BLADE
Applicant
SIERRA SURGICAL, INC.
11315 SUNRISE GOLD CIRCLE,
SUITE L
RANCHO CORDOVA,  CA  95742
Applicant Contact REBECCA ANDERSEN
Correspondent
SIERRA SURGICAL, INC.
11315 SUNRISE GOLD CIRCLE,
SUITE L
RANCHO CORDOVA,  CA  95742
Correspondent Contact REBECCA ANDERSEN
Regulation Number888.3690
Classification Product Code
HSD  
Date Received04/26/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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