The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Orion Central Line Dressing Change Tray.
| Device ID | K941542 |
| 510k Number | K941542 |
| Device Name: | ORION CENTRAL LINE DRESSING CHANGE TRAY |
| Classification | Wrap, Sterilization |
| Applicant | REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-30 |
| Decision Date | 1994-05-23 |