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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Surgical, General & Plastic Surgery
510(k) Number K941399
Device Name OPERATING MICROSCOPE AA OM 10
Applicant
Appasamy Associates (U.S.A.), Inc.
193 Rock Ridge Rd.
Millersville,  MD  21108
Applicant Contact SRINI V SRINIVASAN
Correspondent
Appasamy Associates (U.S.A.), Inc.
193 Rock Ridge Rd.
Millersville,  MD  21108
Correspondent Contact SRINI V SRINIVASAN
Regulation Number878.4700
Classification Product Code
FSO  
Date Received03/22/1994
Decision Date 04/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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