The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Cath Seal.
| Device ID | K962180 |
| 510k Number | K962180 |
| Device Name: | CATH SEAL |
| Classification | Introducer, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 2906 ROUTE 9 Ballston Spa, NY 12020 |
| Contact | Richard Linkert |
| Correspondent | Richard Linkert UNIVERSAL MEDICAL INSTRUMENT CORP. 2906 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 | 1996-06-06 |
| Decision Date | 1996-11-07 |