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510(k) K884660

Device
BIOSONIC ULTRASONIC CLEANING SYSTEM
Applicant
WHALEDENT INTL. DIV. IPCO
510(k) number
K884660
Product code
FLG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-16
Date received
1988-11-07
Regulation
880.6150
Classification name
Cleaner, Ultrasonic, Medical Instrument
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
L WOLFSON
Address
Consultant 36 Maplewood Rd. Hartsdale NY US 10530 10530

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944950KLENZYMECalgon Corp.1994-12-20
K944494ALSA-KLENZCalgon Vestal Div.1994-10-19
K944033BILL EVANS-KLENZCalgon Vestal Div.1994-10-07
K940263NPH-KLENZCalgon Corp.1994-05-18
K941163MON-KLENZCalgon Vestal Div.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
K862282RAPIDEX BIOLOGICAL SURFACTANTRapidex of London1987-05-11
K861147UCS-2, ULTRASONIC CLEANING SOLUTIONKeymed, Inc.1986-06-23
K861588WECK INSTRUMENT CLEANER, CAT. NO. 850-103Palmetto Chemical & Supply Co., Inc.1986-06-17
K861590WEC-KLEEN, CATALOG N. 850-102Palmetto Chemical & Supply Co., Inc.1986-06-17
K861592WEC-WASH, CATALOG NO. 850-115Palmetto 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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