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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 K871473
Device Name PART #860065 IA PAK & PART #860060 IA PAK
Applicant
MEDICAL TECHNICAL PRODUCTS
14 HUGHES STREET, SUITE B104
IRVINE,  CA  92718
Applicant Contact THOMAS V KEELEY
Correspondent
MEDICAL TECHNICAL PRODUCTS
14 HUGHES STREET, SUITE B104
IRVINE,  CA  92718
Correspondent Contact THOMAS V KEELEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received04/14/1987
Decision Date 08/10/1987
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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