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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
Applicant
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent 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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