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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Knife, Orthopedic
510(k) Number K842820
Device Name ARTHROSCOPY KNIVES
Applicant
Medtech Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medtech Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.4540
Classification Product Code
HTS  
Date Received07/19/1984
Decision Date 08/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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