MITEK MINI ANCHOR

Strip, Dialysate Ph Indicator

MITEK SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Mini Anchor.

Pre-market Notification Details

Device IDK936311
510k NumberK936311
Device Name:MITEK MINI ANCHOR
ClassificationStrip, Dialysate Ph Indicator
Applicant MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
ContactEdward F Kent
CorrespondentEdward F Kent
MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
Product CodeMNV  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-20
Decision Date1995-10-31

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