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510(k) K894612

Device
INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
Applicant
INTERTECH RESOURCES, INC.
510(k) number
K894612
Product code
NHK  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-08
Date received
1989-07-20
Regulation
868.5905
Classification name
Resuscitator, Manual, Non Self-inflating
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES W POPE
Address
5100 Tice St. Fort Myers FL US 33905 33905

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NHK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERA Plus Medical2009-11-23
K020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.2002-02-11
K013308VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.2001-12-20
K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury Medical2000-11-03
K970785SIMS HYPERINFLATION BAG SYSTEMSims1997-06-13
K952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.1995-06-08
K942571HYPER-INFLATION BAGMed-Plastics Intl., Inc.1994-06-10
K940255HYPERINFLATION BAG SYSTEMNutec, Inc.1994-02-17
K813317DISP. HYPERINFLATION BAG SYSTEMIntec Medical, Inc.1982-03-12

Legacy Summary#

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FDA Review#

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