The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Dial Medical Kit.
| Device ID | K941543 |
| 510k Number | K941543 |
| Device Name: | DIAL MEDICAL KIT |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| 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 | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-30 |
| Decision Date | 1995-02-16 |