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.
Device ID | K102336 |
510k Number | K102336 |
Device Name: | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE |
Classification | Forceps, Biopsy, Bronchoscope (non-rigid) |
Applicant | Boston Scientific Corporation 2546 FIRST STREET, PROPARK Alajuela, CR |
Contact | Ashley Pyle |
Correspondent | Ashley Pyle Boston Scientific Corporation 2546 FIRST STREET, PROPARK Alajuela, CR |
Product Code | BWH |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-18 |
Decision Date | 2011-01-24 |
Summary: | summary |