The following data is part of a premarket notification filed by Delta Industries, Inc. with the FDA for Bronchoscope Accessory, Nsn 6515-00-315-2200.
Device ID | K911922 |
510k Number | K911922 |
Device Name: | BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200 |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | DELTA INDUSTRIES, INC. P.O. BOX 50128 Idaho Falls, ID 83405 -0128 |
Contact | George S Price |
Correspondent | George S Price DELTA INDUSTRIES, INC. P.O. BOX 50128 Idaho Falls, ID 83405 -0128 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-30 |
Decision Date | 1991-07-29 |