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510(k) K853436

Device
H-H HUNTER PASSIVE TENDON IMPLANT
Applicant
HOLTER-HAUSNER INTL.
510(k) number
K853436
Product code
HXR  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-16
Date received
1985-08-15
Regulation
878.4800
Classification name
Spatula, Orthopedic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN R BOLLES
Address
Third And Mill St.S P.O. Box 100 Bridgeport PA US 19405 19405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K983882MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400Micro-Medical Devices, Inc.1999-03-15
K873387VIDEO ARTHROSCOPE, 1.7MM X 55 MMArthropedics, Inc.1987-11-25
K872281RAYLOR FUSION FUNNELCedar Surgical, Inc.1987-11-02

Legacy Summary#

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FDA Review#

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