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510(k) K864527

Device
DUOCEPH
Applicant
GARY E. HALL, DDS
510(k) number
K864527
Product code
IWY  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-07
Date received
1986-11-17
Regulation
892.1920
Classification name
Holder, Head, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
46850 N. Territorial Plymouth MI US 48170 48170

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.1992-12-28
K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray Systems1989-01-12
K884847MTD HEDRESTComposites Horizons, Inc.1989-01-09
K850197KELLER CEPHALOMETRIC DEVICEGary D. Keller1985-03-22
K844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.1985-03-01
K843340PORTA-STATPorta-Stat, Inc.1984-11-27
K834559DELUXE WALL-MOUNTED CEPHALOMETERKnochen Dental Laboratory1984-02-21
K802140LEKSELL STEREOTACTIC SYSTEMDowns Surgical , Ltd.1981-02-05
K772313X-RAY CO-ORDINATORRinn Corp.1978-01-30

Legacy Summary#

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FDA Review#

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