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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lamp, surgical
510(k) Number K010724
Device Name SOLA 700,SOLA 500, SOLA 300
Original Applicant
DRAGER MEDIZINTECHNIK GMBH
3135 quarry rd.
telford,  PA  18969
Original Contact james j brennan
Regulation Number878.4580
Classification Product Code
FTD  
Date Received03/12/2001
Decision Date 06/07/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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