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510(k) K983947

Device
Amerse 2
Applicant
STERIS Corporation
510(k) number
K983947
Product code
LRJ
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-04
Date received
1998-11-05
Regulation
880.6890
Classification name
Disinfectant, Medical Devices
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL G SARLI
Address
5035 Manchester Ave. St. Louis MO US 63110 63110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992661CONTROL III ELITEMaril Products, Inc.1999-09-14
K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.1999-07-14
K984485MICROSTAT 2Chemlink Laboratories, LLC1999-01-13
K983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.1998-11-30
K983585LOW PH PHENOLIC 256Central Solutions, Inc.1998-11-06
K982985CITREX HOSPITAL SPRAY DISINFECTANTCaltech Industries, Inc.1998-11-02
K981023KLEENASEPTICMetrex Research Corp.1998-04-30
K980369T.B.Q. RTUSTERIS Corporation1998-02-17
K974304GERMICIDAL CLOTHConvatec, A Division of E.R. Squibb & Sons1998-01-13
K961044NOVIGUARD QUICK DRYDr. Novis Smith & Co., Inc.1997-07-03
K970825BLUE CHIP GERMICIDAL CLEANER & DEODORANTS.C. Johnson Professional1997-03-14
K964376CIDE-SWIPES P-100B & CIDE-SWIPES C-100AMp Scientific, Inc.1996-12-23
K964828VIREX II 128 GERMICIDAL CLEANER AND DEODORANTS.C. Johnson & Son, Inc.1996-12-19
K964835COVERAGE SPRAY HBVConvatec, A Division of E.R. Squibb & Sons1996-12-16
K964749COVERAGE HBVConvatec, A Division of E.R. Squibb & Sons1996-12-13