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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
510(k) Number K891001
Device Name MICROSCOPE KNOB COVER, STERILE, DISPOSABLE
Applicant
Prescott'S, Inc.
2915 Vandenburg Ave.
Monument,  CO  80132
Applicant Contact PAUL REDNER
Correspondent
Prescott'S, Inc.
2915 Vandenburg Ave.
Monument,  CO  80132
Correspondent Contact PAUL REDNER
Regulation Number878.4700
Classification Product Code
HRM  
Date Received02/27/1989
Decision Date 04/11/1989
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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