The following data is part of a premarket notification filed by International Marketing Specialists Inc. with the FDA for Tiger Reusable Sharps Container.
Device ID | K203305 |
510k Number | K203305 |
Device Name: | Tiger Reusable Sharps Container |
Classification | Container, Sharps |
Applicant | International Marketing Specialists Inc. 1278 HWY 461 Somerset, KY 42503 |
Contact | Rod Calderon |
Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-09 |
Decision Date | 2021-08-06 |