The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Thoracic Vent.
Device ID | K863561 |
510k Number | K863561 |
Device Name: | URESIL THORACIC VENT |
Classification | Bottle, Collection, Vacuum |
Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Contact | Michael Jaron |
Correspondent | Michael Jaron URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-12 |
Decision Date | 1986-09-23 |