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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K901255
Device Name CUFF BARO GUARD OR CBG ABBREVIATED
Applicant
NELSON ENGINEERING, INC.
1681 RT 80
GUILFORD,  CT  06437
Applicant Contact NELSON KALKREUTH
Correspondent
NELSON ENGINEERING, INC.
1681 RT 80
GUILFORD,  CT  06437
Correspondent Contact NELSON KALKREUTH
Regulation Number868.5750
Classification Product Code
BSK  
Date Received03/15/1990
Decision Date 03/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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