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510(k) K894557

Device
LIGHTSCOPE SET
Applicant
OPTIK
510(k) number
K894557
Product code
HRW  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-07
Date received
1989-07-20
Regulation
888.1250
Classification name
Dynamometer, Nonpowered
Medical specialty
Orthopedic
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAMS M MACFIE
Address
2131espey Ct. Suite 7 Criftib MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971407JTECH COMMANDER AND ALGOMETERJ-Tech Medical, Inc.1998-04-20
K970870DIGIT-GRIP WITH LCD (DGR002)Nk Biotechnical Corp.1997-05-02
K861396HANDHELD DYNAMOMETER, MODEL #160 AND #111Spark Instruments & Academics, Inc.1986-05-02
K821631PINCH GAUGE, 0-301 LBS.Fred Sammons, Inc.1982-06-11
K812343PINCH METERFred Sammons, Inc.1981-09-11
K801719BK-7531 PAIN THRESHOLD/FINGER FORCE GAUGFred Sammons, Inc.1980-08-04
K791021MUSCLE TESTING GUNThe Orthodyn Co.1979-06-15
K790302PRESSURE MONITOR, MODEL 212Zatek1979-03-21
K772413PINCH GUAGEFred Sammons, Inc.1978-01-05
K772415DYNAMETER 50 LB.Fred Sammons, Inc.1978-01-05
K771288JAMAR DYNAMOMETEO BK-7498Fred Sammons, Inc.1977-07-21

Legacy Summary#

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FDA Review#

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