PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

PARAGON MEDICAL, INC.

The following data is part of a premarket notification filed by Paragon Medical, Inc. with the FDA for Paragon Medical Surgical Instrument Delivery System Various.

Pre-market Notification Details

Device IDK032119
510k NumberK032119
Device Name:PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant PARAGON MEDICAL, INC. 7822 LADUE GLEN Fort Wayne,  IN  46804
ContactDavid C Furr
CorrespondentDavid C Furr
PARAGON MEDICAL, INC. 7822 LADUE GLEN Fort Wayne,  IN  46804
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-09
Decision Date2003-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885554033410 K032119 000
00847399015921 K032119 000
00847399005878 K032119 000
00847399003782 K032119 000
00847399017345 K032119 000
00847399006295 K032119 000
00847399004840 K032119 000

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