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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name knife, ophthalmic
510(k) Number K852828
Device Name BEAVER R-K KNIFE
Applicant
RUDOLPH BEAVER, INC.
411 WAVERLEY OAKS RD.
P.O. BOX 9097
WALTHAM,  MA  02154
Applicant Contact ED LEE
Correspondent
RUDOLPH BEAVER, INC.
411 WAVERLEY OAKS RD.
P.O. BOX 9097
WALTHAM,  MA  02154
Correspondent Contact ED LEE
Regulation Number886.4350
Classification Product Code
HNN  
Date Received07/02/1985
Decision Date 11/04/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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