The following data is part of a premarket notification filed by R.l. Medical Corp. with the FDA for Urodynamic Catheters.
| Device ID | K923464 |
| 510k Number | K923464 |
| Device Name: | URODYNAMIC CATHETERS |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | R.L. MEDICAL CORP. 45 WEST ST. SUITE Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale R.L. MEDICAL CORP. 45 WEST ST. SUITE Attleboro, MA 02703 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-14 |
| Decision Date | 1993-02-05 |