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 |