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510(k) K897171

Device
DISPOSABLE CO2 ABSORBER/E
Applicant
GIBECK, INC.
510(k) number
K897171
Product code
CBL  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-13
Date received
1989-12-28
Regulation
868.5300
Classification name
Absorbent, Carbon-dioxide
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL E DRYDEN
Address
10640 E. 59th St. P.O. Box 36430 Indianapolis IN US 46236 46236

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921803SOFNOLIME CARBON DIOXIDE ABSORBENTMolecular Products , Ltd.1992-10-15
K860147CARBON DIOXIDE ABSORBENTSDentsply Intl.1986-02-28
K853571MEDIPART SODA LIME MP-3522Medipart Jerry Alexander1985-10-29
K811260BARALYME CO2 ABSORBENTAllied Healthcare Products, Inc.1981-05-27

Legacy Summary#

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FDA Review#

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