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510(k) K792501

Device
PLS MINI
Applicant
STAODYNAMICS, INC.
510(k) number
K792501
Product code
BWJ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-26
Date received
1979-12-04
Regulation
880.5580
Classification name
Locator, Acupuncture Point
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BWJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792529POINT LOCATOR STIMULATORStaodynamics, Inc.1980-02-26
K772424RYUSEIErcona Corp.1978-05-09

Legacy Summary#

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FDA Review#

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