The following data is part of a premarket notification filed by Medical Safety Products, Inc. with the FDA for Lok-on Needle Disposal Container.
Device ID | K942624 |
510k Number | K942624 |
Device Name: | LOK-ON NEEDLE DISPOSAL CONTAINER |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | MEDICAL SAFETY PRODUCTS, INC. 2751 WEST OXFORD AVE. #5 Englewood, CO 80110 |
Contact | Willliam E Sagstetter |
Correspondent | Willliam E Sagstetter MEDICAL SAFETY PRODUCTS, INC. 2751 WEST OXFORD AVE. #5 Englewood, CO 80110 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-01 |
Decision Date | 1994-08-25 |