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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 K930084
Device Name MICRO-ARTHROSCOPE
Applicant
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact SAMUEL DICKSTEIN
Correspondent
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact SAMUEL DICKSTEIN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/07/1993
Decision Date 09/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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