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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 K833962
Device Name KPE PLUS-PAK SURGICAL SYSTEM
Applicant
IPAX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
IPAX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/16/1983
Decision Date 03/12/1984
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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