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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K032119
Device Name PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
Applicant
PARAGON MEDICAL, INC.
7822 LADUE GLEN
FORT WAYNE,  IN  46804
Applicant Contact DAVID C FURR
Correspondent
PARAGON MEDICAL, INC.
7822 LADUE GLEN
FORT WAYNE,  IN  46804
Correspondent Contact DAVID C FURR
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/09/2003
Decision Date 10/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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