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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name headlight, fiberoptic focusing
510(k) Number K883480
Device Name MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. 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 Number886.4335
Classification Product Code
FCT  
Date Received08/16/1988
Decision Date 08/24/1988
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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