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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K871180
Device Name ARTHRO AUTOMAT 5002
Applicant
F.M. Wiest USA, Inc.
1301 N. Kings Hwy.
Cherry Hill,  NJ  08034
Applicant Contact WAYNE W DISANZA
Correspondent
F.M. Wiest USA, Inc.
1301 N. Kings Hwy.
Cherry Hill,  NJ  08034
Correspondent Contact WAYNE W DISANZA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/25/1987
Decision Date 09/29/1987
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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