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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, surgical instrument, disposable
510(k) Number K971317
Device Name NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
Applicant
NATIONAL HEALTHCARE MFG. CORP.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CAROLANN KOTULA
Correspondent
NATIONAL HEALTHCARE MFG. CORP.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CAROLANN KOTULA
Regulation Number878.4800
Classification Product Code
KDD  
Date Received04/09/1997
Decision Date 05/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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