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510(k) K953645

Device
OLYMPIC PASTEURMATIC SYSTEM
Applicant
OLYMPIC MEDICAL CORP.
510(k) number
K953645
Product code
LDS  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-22
Date received
1995-08-04
Regulation
880.6991
Classification name
Device, Pasteurization, Hot Water
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH P STEFANILE
Address
5900 First Ave. S. Seattle WA US 98108 98108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LDS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183444Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level DisinfectorCenorin, LLC2019-09-09
K031799MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881Miele, Inc.2003-11-12
K983068RELIANCE FAMILY OF WASHER-DISINFECTORSSTERIS Corporation2000-05-31
K972193OLYMPIX MINI-PASTEURMATIC (58210)Olympic Medical Corp.1997-09-05
K950518MIELE G 7781 DENTAL THERMAL DISINFECTORMiele Professional1996-01-26
K950566DECOMAT 4656Getinge Disinfection, Inc.1995-10-19
K884151MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.Miele Appliances, Inc.1989-05-16
K860263CASTLE 7538 FLOOR LOADING WASHERCastle Co.1986-03-05
K844089CASTLE 7515 UTENSIL/GLASSWARE WASHERCastle Co.1985-01-14
K810311STERI-VERSThe Hilrad Co.1981-04-17

Legacy Summary#

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FDA Review#

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