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510(k) K920492

Device
HIGH VAC
Applicant
HYGOPLASTIC, INC.
510(k) number
K920492
Product code
DYN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-11
Date received
1992-02-03
Regulation
872.6640
Classification name
Mouthpiece, Saliva Ejector
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GUNNAR WALLIN
Address
1494 Lakeshore Rd. Grafton WI US 53024 53024

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflex1994-08-17
K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing AB1994-03-21
K935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.1994-03-21
K924211EJECTORGlenroe Technologies1993-03-31
K921117MINIDAMDelsan Dental Systems1992-05-05
K900631SALIVA ABSORBER - DENTALKab Gloves Unltd.1990-04-04
K871315ORAL ASPIRATOREndovations1987-04-15
K870599TIP, DENTAL SUCTION APPARATUSMilitary Engineering, Inc.1987-03-23
K864300SILIVA EJECTOR/ORAL CAVITY EVACUATORArdent Intl., Inc.1986-11-24
K863768SALIVA EJECTORSThe Medical Group, Inc.1986-10-27
K863163ULS 8-86American Instrument Manufacturer'S, Inc.1986-09-22
K861934SALIVA EJECTORCarlisle Laboratories, Inc.1986-06-09
K801927SILENTSLEEPSlumber Research, Inc.1980-11-14
K800210TONGUE HOLDER/SALIVA EJECTORUnitek Corp.1980-02-06
K781592SURGICAL ASPIRATOR TIPSHenry Schein, Inc.1978-12-04

Legacy Summary#

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FDA Review#

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