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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Microscope, Ophthalmic
510(k) Number K902851
Device Name MICROSCOPE DRAPE
Applicant
Medical Technique Instruments, Inc.
16541 Redmond Way
Suite 362-C
Redmond,  WA  98052
Applicant Contact LOU CASTAGNA
Correspondent
Medical Technique Instruments, Inc.
16541 Redmond Way
Suite 362-C
Redmond,  WA  98052
Correspondent Contact LOU CASTAGNA
Regulation Number878.4370
Classification Product Code
HMW  
Date Received06/29/1990
Decision Date 09/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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