510(k) K962688

MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE by Boston Medical Products, Inc. — Product Code KCF

K962688 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE". The FDA issued a decision of Substantially Equivalent on July 25, 1996. The device falls under product code KCF (Dilator, Esophageal, Ent), a Class I device regulated under 21 CFR 874.4420. Boston Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
July 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type