The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil 150cc Bellows Reservoir.
Device ID | K863562 |
510k Number | K863562 |
Device Name: | URESIL 150CC BELLOWS RESERVOIR |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
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 | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-12 |
Decision Date | 1986-09-29 |