FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CARBON DIOXIDE ABSORBENTS

K Number: K860147 · Decision Feb 28, 1986
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
4
Applicant Total
279
Review Days
44

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Basic Information

Device Name
CARBON DIOXIDE ABSORBENTS
K Number
K860147
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5300
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Dentsply Intl.
Date Received
January 15, 1986
Decision Date
February 28, 1986
Product Code
CBL
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CBL Absorbent, Carbon-Dioxide

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K051707 ECLIPSE BONDING AGENT
K051463 XENO ADHESIVE WITH ACTIVATOR
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K050880 DYRACT EXTRA RESTORATIVE
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