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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K874725
Device Name SITE SOLUTION ADMINISTRATION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received11/18/1987
Decision Date 04/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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