The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Braided Catheter Connector.
| Device ID | K897128 |
| 510k Number | K897128 |
| Device Name: | UMI BRAIDED CATHETER CONNECTOR |
| Classification | Latex Patient Examination Glove |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | M Copperberg |
| Correspondent | M Copperberg UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-03-01 |