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510(k) K983882

Device
MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
Applicant
MICRO-MEDICAL DEVICES, INC.
510(k) number
K983882
Product code
HXR  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-15
Date received
1998-11-02
Regulation
878.4800
Classification name
Spatula, Orthopedic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JIM OHNECK
Address
11000 Cedar Ave. Suite 445 Cleveland OH US 44106 44106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HXR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873387VIDEO ARTHROSCOPE, 1.7MM X 55 MMArthropedics, Inc.1987-11-25
K872281RAYLOR FUSION FUNNELCedar Surgical, Inc.1987-11-02
K853436H-H HUNTER PASSIVE TENDON IMPLANTHolter-Hausner Intl.1985-10-16

Legacy Summary#

summary

FDA Review#

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