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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K925921
Device Name MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
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 Number886.4360
Classification Product Code
KYG  
Date Received11/23/1992
Decision Date 12/06/1993
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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