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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 K922077
Device Name MODIFIED SITE POWER HANDPIECE
Applicant
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact BRNT MILLER
Correspondent
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact BRNT MILLER
Regulation Number872.4200
Classification Product Code
EKX  
Date Received05/04/1992
Decision Date 06/23/1992
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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