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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name arthroscope
510(k) Number K980734
Device Name MYELOTEC VIDEO GUIDED CATHETER
Applicant
MYELOTEC, INC.
4000 NORTHFIELD WAY, SUITE 900
ROSWELL,  GA  30076
Applicant Contact THOMAS A DUNKLE
Correspondent
MYELOTEC, INC.
4000 NORTHFIELD WAY, SUITE 900
ROSWELL,  GA  30076
Correspondent Contact THOMAS A DUNKLE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/25/1998
Decision Date 08/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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