The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Cath-seal.
| Device ID | K822247 |
| 510k Number | K822247 |
| Device Name: | CATH-SEAL |
| Classification | Introducer, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-29 |
| Decision Date | 1982-08-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CATH-SEAL 73527599 1412166 Dead/Cancelled |
UNIVERSAL MEDICAL INSTRUMENT CORPORATION 1985-05-13 |