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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 K940088
Device Name MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
Applicant
Medical Technical Products
23042 Alcalde, Suite A
Laguna Hills,  CA  92653
Applicant Contact JAMES H BAKOS
Correspondent
Medical Technical Products
23042 Alcalde, Suite A
Laguna Hills,  CA  92653
Correspondent Contact JAMES H BAKOS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received01/07/1994
Decision Date 08/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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