The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Endoscopic Laser Overtube.
| Device ID | K901882 |
| 510k Number | K901882 |
| Device Name: | URESIL ENDOSCOPIC LASER OVERTUBE |
| Classification | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | M Goldberg,md |
| Correspondent | M Goldberg,md URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | KOQ |
| CFR Regulation Number | 872.3410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-26 |
| Decision Date | 1990-07-27 |