The following data is part of a premarket notification filed by Info-chem with the FDA for Keep-account Sharps Disposal System.
Device ID | K810134 |
510k Number | K810134 |
Device Name: | KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM |
Classification | Container, Sharps |
Applicant | INFO-CHEM 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-19 |
Decision Date | 1981-02-26 |