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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name refractometer, ophthalmic
510(k) Number K862521
Device Name BAUSCH & LOMB GR-3 REFRACTOR
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O.BOX 450
ROCHESTER,  NY  14692
Applicant Contact NICHOLAS A WALP
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O.BOX 450
ROCHESTER,  NY  14692
Correspondent Contact NICHOLAS A WALP
Regulation Number886.1760
Classification Product Code
HKO  
Date Received07/01/1986
Decision Date 07/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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