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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Biopsy, Bronchoscope (Rigid)
510(k) Number K932853
Device Name PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
Applicant
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Applicant Contact SCOTT HUNTLEY
Correspondent
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Correspondent Contact SCOTT HUNTLEY
Regulation Number874.4680
Classification Product Code
JEL  
Date Received06/10/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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