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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 K931323
Device Name MOUNTABLE KNIFE
Applicant
Esco Medical
21 William Penn Dr.
Stony Brook,  NY  11790
Applicant Contact THEODOR ESSER
Correspondent
Esco Medical
21 William Penn Dr.
Stony Brook,  NY  11790
Correspondent Contact THEODOR ESSER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/16/1993
Decision Date 04/28/1994
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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