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510(k) K812305

Device
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE
Applicant
BOSTON MEDICAL PRODUCTS, INC.
510(k) number
K812305
Product code
KCF  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-08
Date received
1981-08-17
Regulation
874.4420
Classification name
Dilator, Esophageal, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K923355PHARYNGEAL SALIVARY BYPASS TUBEBoston Medical Products, Inc.1992-10-06

Legacy Summary#

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FDA Review#

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