The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Wang Bronchial Needle Brush.
Device ID | K944650 |
510k Number | K944650 |
Device Name: | WANG BRONCHIAL NEEDLE BRUSH |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
Contact | Alan C Poje |
Correspondent | Alan C Poje MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-21 |
Decision Date | 1994-11-22 |