CATH-SEAL
Introducer, Catheter
UNIVERSAL MEDICAL INSTRUMENT CORP.
The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Cath-seal.
Pre-market Notification Details
| Device ID | K935077 |
| 510k Number | K935077 |
| Device Name: | CATH-SEAL |
| Classification | Introducer, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 2905 ROUTE 9 Ballston Spa, NY 12020 |
| Contact | Deron A Jordan |
| Correspondent | Deron A Jordan UNIVERSAL MEDICAL INSTRUMENT CORP. 2905 ROUTE 9 Ballston Spa, NY 12020 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-22 |
| Decision Date | 1994-06-07 |
Trademark Results [CATH-SEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CATH-SEAL 73527599 1412166 Dead/Cancelled |
UNIVERSAL MEDICAL INSTRUMENT CORPORATION 1985-05-13 |
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