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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
LUEBECK,  DE D-23542
Applicant Contact FRANK CLANZETT
Correspondent
DRAGER MEDIZINTECHNIK GMBH
53/55 MOISLINGER ALLEE
LUEBECK,  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
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