RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE

Forceps, Biopsy, Bronchoscope (non-rigid)

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps With Ne.

Pre-market Notification Details

Device IDK102336
510k NumberK102336
Device Name:RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
ClassificationForceps, Biopsy, Bronchoscope (non-rigid)
Applicant Boston Scientific Corporation 2546 FIRST STREET, PROPARK Alajuela,  CR
ContactAshley Pyle
CorrespondentAshley Pyle
Boston Scientific Corporation 2546 FIRST STREET, PROPARK Alajuela,  CR
Product CodeBWH  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-18
Decision Date2011-01-24
Summary:summary

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