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510(k) K843340

Device
PORTA-STAT
Applicant
PORTA-STAT, INC.
510(k) number
K843340
Product code
IWY  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-27
Date received
1984-08-27
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#

Contact
JOHN L SPOLYAR
Address
35129 Dodge Park Rd. Sterling Heights MI US 48077 48077

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
K864527DUOCEPHGary E. Hall, Dds1987-01-07
K850197KELLER CEPHALOMETRIC DEVICEGary D. Keller1985-03-22
K844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.1985-03-01
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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