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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Ultraviolet
510(k) Number K934728
Device Name SUNSOR ULTRAVIOLET METER
Applicant
Sunsor, Inc.
1388 Freeport Rd.
Pittsburgh,  PA  15238
Applicant Contact STEPHEN J SHERWIN
Correspondent
Sunsor, Inc.
1388 Freeport Rd.
Pittsburgh,  PA  15238
Correspondent Contact STEPHEN J SHERWIN
Regulation Number872.6350
Classification Product Code
EAQ  
Date Received09/29/1993
Decision Date 07/28/1994
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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