The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Orion All Silicone Elastomer Coated Catheter.
| Device ID | K944376 |
| 510k Number | K944376 |
| Device Name: | ORION ALL SILICONE ELASTOMER COATED CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | REGULATORY & MARKETING SERVICES, INC. 1247 FLORIDA AVE. Palm Harbor, FL 34682 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb REGULATORY & MARKETING SERVICES, INC. 1247 FLORIDA AVE. 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 | 1994-09-07 |
| Decision Date | 1994-11-30 |