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510(k) K911784

Device
NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
Applicant
NORTH AMERICAN STERILIZATION & PACKAGING CO.
510(k) number
K911784
Product code
BTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-09-23
Date received
1991-04-22
Regulation
868.5100
Classification name
Airway, Nasopharyngeal
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HARRY A SCHLAKMAN
Address
15 White Lake Rd. P.O. Box 923 Sparta NJ US 07871 07871

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BTQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940320AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGSAd-Tech Medical Instrument Corp1995-09-19
K921353NASOPHARYNGEAL AIRWAYCoast Medical Corp.1992-06-11
K903618ROBERTAZZI NASOPHARYNGEAL AIRWAYEastmed Enterprises, Inc.1991-01-08
K900456POLAMEDCO NASOPAHARYNGEAL AIRWAYPolamedco, Inc.1990-04-19
K901279CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAYChatham Industries1990-03-28
K883668SUNDERLAND NASAL TUBEExmoor Plastics , Ltd.1988-11-21
K873949RORERTAZZI NASOPHARYNGEAL AIRWAYPenn Medical Devices, Inc.1987-10-20
K871673NASOPHARYNGEAL AIRWAYHarding Industries, Inc.1987-06-15
K853162STERILE NASOPHARYNGEAL AIRWAYInmed Corp.1985-08-06
K850644NASOPHARYNGEAL AIRWAY-ROBERTAZZIDryden Corp.1985-03-21
K843524LINDER NASOPHARYNGEAL AIRWAYPolamedco, Inc.1984-10-04
K841093NASOPHARYNGEAL AIRWAYSInmed Corp.1984-03-23
K834078SILICONE RUGGER DISPOSABLE YOKE-CPAPVesta, Inc.1983-12-27
K831476NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLEFls Medical Products, Inc.1983-06-10
K830983AIRWAYS & NASOPHARYNGEAL TYPEMedovations, Inc.1983-05-09

Legacy Summary#

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FDA Review#

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