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510(k) K894755

Device
ASTRA DISPOSABLE SPRAY CANNULA
Applicant
ASTRA PHARMACEUTICAL PRODUCTS, INC.
510(k) number
K894755
Product code
CCT  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-12
Date received
1989-07-27
Regulation
868.5170
Classification name
Applicator (laryngo-tracheal), Topical Anesthesia
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID J PIZZI
Address
50 Otis St. Westborough MA US 01581 01581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240114UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor2024-10-16
K172956Medicant Mucosal AtomizerMedica Holdings, LLC2018-04-06
K153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical2016-08-19
K093584EZ-MISTERN.M. Beale Co., Inc.2011-03-04
K070596TOPICAL APPLICATORSharn, Inc.2007-06-21
K002255LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)Wolfe Tory Medical, Inc.2000-09-18
K810059ENDO-MED TUBE FOR ENDOTRACHEAL MEDAckrad Laboratories1981-02-26
K760759ANESTHESIA KITSherwood Medical Industries1976-12-09
K760877MONOJECT LARYNGOTRACHEAL ANESTHESIA KITSherwood Medical Industries1976-12-09

Legacy Summary#

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FDA Review#

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