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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 K945684
Device Name POC ARTHROSCOPE AND ACCESSORIES
Applicant
Precision Optics Corp.
22 E. Broadway
Gardner,  MA  01440
Applicant Contact JAMES A REILLY
Correspondent
Precision Optics Corp.
22 E. Broadway
Gardner,  MA  01440
Correspondent Contact JAMES A REILLY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/21/1994
Decision Date 06/14/1995
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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