FDA 510(k) Application Details - K210200

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K210200
Device Name	Syringe, Piston
Applicant	Set Medikal Sanayi Ve Ticaret Anonim Sirketi Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt Istanbul 34522 TR Other 510(k) Applications for this Company
Contact	Mehice Ozturk Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2021
Decision Date	05/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review