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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, wrist, hemi-, ulnar
510(k) Number K042902
Device Name HERBERT ULNAR HEAD PROSTHESIS SYSTEM
Applicant
STUCKENBROCK MEDIZINTECHNIK GMBH
12244 SW 130 ST.
MIAMI,  FL  33186
Applicant Contact AL WEISENBORN
Correspondent
STUCKENBROCK MEDIZINTECHNIK GMBH
12244 SW 130 ST.
MIAMI,  FL  33186
Correspondent Contact AL WEISENBORN
Regulation Number888.3810
Classification Product Code
KXE  
Date Received10/20/2004
Decision Date 12/27/2004
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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