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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor
510(k) Number K890248
Device Name SURGICAL RETRACTORS
Applicant
KINETIC MEDICAL PRODUCTS
4934 PEACH ST.
ERIE,  PA  16509
Applicant Contact JAMES I LAUGHNER
Correspondent
KINETIC MEDICAL PRODUCTS
4934 PEACH ST.
ERIE,  PA  16509
Correspondent Contact JAMES I LAUGHNER
Regulation Number878.4800
Classification Product Code
GAD  
Date Received01/18/1989
Decision Date 01/27/1989
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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