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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burr, Corneal, Battery-Powered
510(k) Number K883785
Device Name GY-RO SAFE
Applicant
Gy-Ro Industry, Inc.
Box 87794
Houston,  TX  77287
Applicant Contact WM. N WEST
Correspondent
Gy-Ro Industry, Inc.
Box 87794
Houston,  TX  77287
Correspondent Contact WM. N WEST
Regulation Number886.4070
Classification Product Code
HOG  
Date Received09/07/1988
Decision Date 01/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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