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510(k) K962688

Device
MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
Applicant
BOSTON MEDICAL PRODUCTS, INC.
510(k) number
K962688
Product code
KCF  
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-25
Date received
1996-07-11
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
STUART K MONTGOMERY
Address
117 Flanders Rd. Westborough MA US 01581 01581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923355PHARYNGEAL SALIVARY BYPASS TUBEBoston Medical Products, Inc.1992-10-06
K812305MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBEBoston Medical Products, Inc.1981-09-08

Legacy Summary#

summary

FDA Review#

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