The following data is part of a premarket notification filed by Handren Assoc. with the FDA for Qlicksmart.
Device ID | K983367 |
510k Number | K983367 |
Device Name: | QLICKSMART |
Classification | Container, Sharps |
Applicant | HANDREN ASSOC. 5818 PR. CAROLINE PL. Leesburg, FL 34748 |
Contact | Robert T Handren Jr |
Correspondent | Robert T Handren Jr HANDREN ASSOC. 5818 PR. CAROLINE PL. Leesburg, FL 34748 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-24 |
Decision Date | 1998-11-06 |