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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, surgical with orthopedic accessories, manual
510(k) Number K900405
Device Name SCHOLTEN FRAME
Applicant
SCHOLTEN SURGICAL INSTRUMENTS, INC.
100 HEGENBERGER RD.
SUITE 210
OAKLAND,  CA  94621
Applicant Contact J DONALDSON
Correspondent
SCHOLTEN SURGICAL INSTRUMENTS, INC.
100 HEGENBERGER RD.
SUITE 210
OAKLAND,  CA  94621
Correspondent Contact J DONALDSON
Regulation Number878.4950
Classification Product Code
JEB  
Date Received01/29/1990
Decision Date 03/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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