FDA 510(k) Application Details - K222137

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K222137
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, NY 11101 US Other 510(k) Applications for this Company
Contact	Andrew Sharavara Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2022
Decision Date	12/05/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review