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510(k) K944950

Device
KLENZYME
Applicant
CALGON CORP.
510(k) number
K944950
Product code
FLG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-20
Date received
1994-10-07
Regulation
880.6150
Classification name
Cleaner, Ultrasonic, Medical Instrument
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 EBERS
Address
Sub. Merck & Co., Inc. 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 FLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944494ALSA-KLENZCalgon Vestal Div.1994-10-19
K944033BILL EVANS-KLENZCalgon Vestal Div.1994-10-07
K941163MON-KLENZCalgon Vestal Div.1994-05-18
K940263NPH-KLENZCalgon Corp.1994-05-18
K935063INSTRU KLENZCalgon Corp.1994-05-09
K934666PDS ULTRACLEANMedical Polymers, Inc.1994-04-15
K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERSurgicot, Inc.1994-04-13
K933149INSTRUMENT DETERGENT CONCENTRATENobelpharma USA, Inc.1994-02-16
K884660BIOSONIC ULTRASONIC CLEANING SYSTEMWhaledent Intl. Div. Ipco1989-03-16
K862282RAPIDEX BIOLOGICAL SURFACTANTRapidex of London1987-05-11
K861147UCS-2, ULTRASONIC CLEANING SOLUTIONKeymed, Inc.1986-06-23
K861592WEC-WASH, CATALOG NO. 850-115Palmetto Chemical & Supply Co., Inc.1986-06-17
K861590WEC-KLEEN, CATALOG N. 850-102Palmetto Chemical & Supply Co., Inc.1986-06-17
K861588WECK INSTRUMENT CLEANER, CAT. NO. 850-103Palmetto Chemical & Supply Co., Inc.1986-06-17
K861587WECK CONCENTRATED LIQUID CLEANERPalmetto Chemical & Supply Co., Inc.1986-05-19

Legacy Summary#

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FDA Review#

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