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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K905620
Device Name MODIFIED SITE PERISTALTIC FOOTSWITCH
Applicant
Site Microsurgical Systems, Inc.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact BRUNT MILLER
Correspondent
Site Microsurgical Systems, Inc.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact BRUNT MILLER
Regulation Number872.4200
Classification Product Code
EBW  
Date Received12/14/1990
Decision Date 02/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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