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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K905462
Device Name PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES
Applicant
Angiosystems, Inc.
C/O Medical Device Inspeciton
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Angiosystems, Inc.
C/O Medical Device Inspeciton
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number878.4800
Classification Product Code
LRP  
Date Received12/05/1990
Decision Date 02/06/1991
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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