The following data is part of a premarket notification filed by Med-safe Systems, Inc. with the FDA for Vacutainer Brand Needle Disposal Container.
Device ID | K943138 |
510k Number | K943138 |
Device Name: | VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER |
Classification | Container, Sharps |
Applicant | MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside, CA 92056 -3590 |
Contact | Virginia Shillington |
Correspondent | Virginia Shillington MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside, CA 92056 -3590 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-29 |
Decision Date | 1994-11-28 |