FDA 510(k) Application Details - K203305

Device Classification Name	Container, Sharps   More FDA Info for this Device
510(K) Number	K203305
Device Name	Container, Sharps
Applicant	International Marketing Specialists Inc. 1278 HWY 461 Somerset, KY 42503 US Other 510(k) Applications for this Company
Contact	Rod Calderon Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	MMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2020
Decision Date	08/06/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review