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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K910980
Device Name SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
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 Number886.1850
Classification Product Code
HJO  
Date Received03/07/1991
Decision Date 05/22/1991
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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