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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Ceiling Mounted
510(k) Number K984611
Device Name DRAGER SOLA SERIES, MODELS 1000/700/500/300
Applicant
Drager Medizintechnik GmbH
53/55 Moislinger Allee
Lubeck,  DE D-23542
Applicant Contact FRANK CLANZETT
Correspondent
Drager Medizintechnik GmbH
53/55 Moislinger Allee
Lubeck,  DE D-23542
Correspondent Contact FRANK CLANZETT
Regulation Number878.4580
Classification Product Code
FSY  
Date Received12/29/1998
Decision Date 03/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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