The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Percutaneous Catheter Introducer W/cath-seal & Sid.
| Device ID | K850820 |
| 510k Number | K850820 |
| Device Name: | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID |
| Classification | Introducer, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | Charles M Cooperber |
| Correspondent | Charles M Cooperber UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 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 | 1985-02-28 |
| Decision Date | 1985-04-10 |