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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, ceiling mounted
510(k) Number K891756
Device Name KINETIC MODEL 500
Applicant
KINETIC BIOMEDICAL SERVICES, INC.
4934 PEACH ST.
ERIE,  PA  16509
Applicant Contact JAMES I LAUGHNER
Correspondent
KINETIC BIOMEDICAL SERVICES, INC.
4934 PEACH ST.
ERIE,  PA  16509
Correspondent Contact JAMES I LAUGHNER
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/23/1989
Decision Date 04/19/1989
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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