VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

T.A.G. MEDICAL PRODUCTS

The following data is part of a premarket notification filed by T.a.g. Medical Products with the FDA for Versitomic Acl Flexible Reamer System Sterilization Tray.

Pre-market Notification Details

Device IDK100887
510k NumberK100887
Device Name:VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset,  MA  02726
ContactGeorge J Hattub
CorrespondentGeorge J Hattub
T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset,  MA  02726
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-30
Decision Date2010-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327163025 K100887 000
10810190013080 K100887 000
10810190013073 K100887 000
10810190010126 K100887 000
10810128460993 K100887 000
10810128460771 K100887 000
10810128460764 K100887 000
10810128460757 K100887 000

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