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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K982789
Device Name MEDICAL AIR COMPRESSOR, MODEL # 8413419
Applicant
DRAGER, INC.
3136 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact HARALD KNEUER
Correspondent
DRAGER, INC.
3136 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact HARALD KNEUER
Regulation Number868.6250
Classification Product Code
BTI  
Date Received08/10/1998
Decision Date 10/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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