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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K073066
Device Name 308 DERMATOLOGICAL EXCIMER SYSTEM
Applicant
QUANTEL MEDICAL, INC.
377 ROUTE 17
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
QUANTEL MEDICAL, INC.
377 ROUTE 17
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/30/2007
Decision Date 12/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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