The following data is part of a premarket notification filed by Bryan Corp. with the FDA for Dumon/harrell.
Device ID | K854414 |
510k Number | K854414 |
Device Name: | DUMON/HARRELL |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
Contact | Frank M Abrano |
Correspondent | Frank M Abrano BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-04 |
Decision Date | 1986-03-12 |