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510(k) K855021

Device
LARYNGEAL MIRROR PRE-WARMER
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K855021
Product code
ETF  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-20
Date received
1985-12-16
Regulation
874.5300
Classification name
Unit, Examining/treatment, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CRAIG RAPP
Address
1430 Hanley Industrial Ct. St. Louis MO US 63144 63144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ETF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953457JEDMED SPECTRUM ENT CABINETJedmed Instrument Co.1995-08-11
K945395PREMIER MIRROR WARMERPremier Dental Products Co.1995-01-18
K932470LANGGASSE 90Happersberger Otopront GmbH1993-08-25
K911901MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCEStortz1991-07-26
K910781#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCESMidmark Corp.1991-05-15
K910243MOBILE TREATMENT CARTJedmed Instrument Co.1991-04-17
K896273SYSTEMA ENT CABINETJedmed Instrument Co.1990-01-26
K896298JEDMED S CHAIRJedmed Instrument Co.1990-01-26
K881958JEDMED MAXIM ENT CABINETJedmed Instrument Co.1988-07-15
K860940MICROMEDICS STERILE, DISPOSABLE ENT EXAM KITMicromedics, Inc.1986-05-02
K843046RELIANCE TREATMENT CABINETF. & F. Koenigkramer1984-09-27
K833882INSTRUMENT CABINETJedmed Instrument Co.1984-01-27
K823226SN-100 DOCTOR'S ROUNDKells Medical, Inc.1982-11-22
K822252ENT TREATMENT UNITSKelleher Corp.1982-11-22
K822531MULTIPLE, ENT CABINET #448Midmark Corp.1982-09-28

Legacy Summary#

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FDA Review#

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