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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K922544
Device Name MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
Applicant
KIRSCHNER MEDICAL CORP.
63 SOUTH ST.
HOPKINTON,  MA  01748
Applicant Contact PATRICIA CARPENTER
Correspondent
KIRSCHNER MEDICAL CORP.
63 SOUTH ST.
HOPKINTON,  MA  01748
Correspondent Contact PATRICIA CARPENTER
Regulation Number878.4580
Classification Product Code
FST  
Date Received05/29/1992
Decision Date 08/07/1992
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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