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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 K912739
Device Name SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
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 Received06/21/1991
Decision Date 08/28/1991
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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