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510(k) K903012

Device
AUDIOPRAT ENDOSCOPE
Applicant
S.C.D.P.I. OF FLORIDA, INC.
510(k) number
K903012
Product code
EHB  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-09
Date received
1990-07-11
Regulation
872.1840
Classification name
Collimator, X-ray
Medical specialty
Dental
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CLAUDE D BERTHOIN
Address
256 N. Nova Rd., Suite 38 Ormond Beach FL US 32174 32174

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921355WINGMASTERInnovators, Inc.1992-09-25
K834606X-RAY COLLIMATOR X-CJDKnochen Dental Laboratory1984-02-21
K833558X-RAY SHIELDMoyco Industries, Inc.1984-01-13
K781675X-RAY COLLIMATORGeneral X-Ray, Inc.1978-12-04

Legacy Summary#

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FDA Review#

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