The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Board, Disposable Control Count.
Device ID | K781791 |
510k Number | K781791 |
Device Name: | BOARD, DISPOSABLE CONTROL COUNT |
Classification | Container, Sharps |
Applicant | DEXIDE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-20 |
Decision Date | 1978-11-08 |