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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, cutting, orthopedic
510(k) Number K853678
Device Name KAMBIN SPINAL INSTRUMENT SET
Applicant
PILLING CO.
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Applicant Contact LELAND J WIMER
Correspondent
PILLING CO.
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Correspondent Contact LELAND J WIMER
Regulation Number878.4800
Classification Product Code
HTZ  
Date Received09/03/1985
Decision Date 09/24/1985
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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