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510(k) K853726

Device
LARYNGEAL
Applicant
HOOD LABORATORIES
510(k) number
K853726
Product code
FWN  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-12
Date received
1985-09-06
Regulation
874.3620
Classification name
Prosthesis, Larynx (stents And Keels)
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE BARBER
Address
575 Washington St. Pembroke MA US 02359 02359

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091135RUTTER SUPRA STOMAL STENTSBoston Medical Products, Inc.2009-09-14
K000154ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1E. Benson Hood Lab, Inc.2000-03-29
K962693MONTGOMERY RADIOPAQUE LARYNGEAL KEELBoston Medical Products, Inc.1996-08-09
K896667LORENZ STENTWalter Lorenz Surgical, Inc.1990-02-22
K884810SILICONE LARYNGEAL STENTHood Laboratories1989-05-10
K864936'EXMOOR' DAS GUPTA LARYNGEAL KEELExmoor Plastics , Ltd.1987-04-27
K842800MONTG. LARYNGEAL KEELBoston Medical Products, Inc.1984-08-02
K842287MONTGOMERY LARYNGEAL STENTBoston Medical Products, Inc.1984-06-27
K841347LARYNGEAL STENTE. Benson Hood Laboratories, Inc.1984-05-02

Legacy Summary#

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FDA Review#

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