FDA.reportPublic FDA data

510(k) K923355

Device
PHARYNGEAL SALIVARY BYPASS TUBE
Applicant
BOSTON MEDICAL PRODUCTS, INC.
510(k) number
K923355
Product code
KCF  
Decision
Substantially Equivalent (SESE)
Decision date
1992-10-06
Date received
1992-07-08
Regulation
874.4420
Classification name
Dilator, Esophageal, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STUART K MONTGOMERY
Address
87 Rumford Ave. Waltham MA US 02154 02154

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962688MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBEBoston Medical Products, Inc.1996-07-25
K812305MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBEBoston Medical Products, Inc.1981-09-08

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases