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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K932600
Device Name MODIFIED SITE POWER HANDPIECE II
Applicant
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact BRUNT MILLER
Correspondent
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact BRUNT MILLER
Regulation Number872.4200
Classification Product Code
EKX  
Date Received05/28/1993
Decision Date 01/25/1994
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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