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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 K882103
Device Name SITE ULTRASONIC I/A PHACO NEEDLE
Applicant
SITE MICROSURGICAL SYSTEMS, INC.
135 GIBRALTAR RD.
HORSHAM,  PA  19044
Applicant Contact JAMES K MCCRACKEN
Correspondent
SITE MICROSURGICAL SYSTEMS, INC.
135 GIBRALTAR RD.
HORSHAM,  PA  19044
Correspondent Contact JAMES K MCCRACKEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/19/1988
Decision Date 07/01/1988
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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