The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Dial Medical Supply Sharps Container.
| Device ID | K944230 |
| 510k Number | K944230 |
| Device Name: | DIAL MEDICAL SUPPLY SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Contact | Partrick J Lamb |
| Correspondent | Partrick J Lamb REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1994-11-07 |