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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osteotome, Manual
510(k) Number K933181
Device Name VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact CHARLES COPPERBERG
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact CHARLES COPPERBERG
Regulation Number878.4800
Classification Product Code
GFI  
Date Received06/30/1993
Decision Date 11/02/1993
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
Predetermined Change
Control Plan Authorized		 No
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