The following data is part of a premarket notification filed by Excalibur Engineering Care Of Rms, Inc. with the FDA for Frangi-cath Safe-release(tm) Connector.
| Device ID | K932809 |
| 510k Number | K932809 |
| Device Name: | FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | EXCALIBUR ENGINEERING CARE OF RMS, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb EXCALIBUR ENGINEERING CARE OF RMS, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1994-03-17 |