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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 K833697
Device Name EXTRA SENSORY PAK-DISPOS. ACCESS
Applicant
AMERICAN SURGICAL CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN SURGICAL CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/18/1983
Decision Date 12/28/1983
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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