The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Orion Suction Catheter Kit With Sterile Water.
| Device ID | K942273 |
| 510k Number | K942273 |
| Device Name: | ORION SUCTION CATHETER KIT WITH STERILE WATER |
| Classification | Catheter, Irrigation |
| Applicant | REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Contact | Patrick Lamb |
| Correspondent | Patrick Lamb REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-10 |
| Decision Date | 1994-06-02 |