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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K850532
Device Name ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK
Applicant
ATLANTIC OPTICAL SYSTEMS, INC.
P.O. BOX 510
LEECHBURG,  PA  15656
Applicant Contact WILLIAM J BOYLE
Correspondent
ATLANTIC OPTICAL SYSTEMS, INC.
P.O. BOX 510
LEECHBURG,  PA  15656
Correspondent Contact WILLIAM J BOYLE
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/11/1985
Decision Date 04/15/1985
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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