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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name absorbent, carbon-dioxide
510(k) Number K860147
Device Name CARBON DIOXIDE ABSORBENTS
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Applicant Contact JOHN O SEMMELMAN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Correspondent Contact JOHN O SEMMELMAN
Regulation Number868.5300
Classification Product Code
CBL  
Date Received01/15/1986
Decision Date 02/28/1986
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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