MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE

Instrument, Biopsy

MANAN MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Bio-cut Soft Tissue Biopsy Needle.

Pre-market Notification Details

Device IDK052802
510k NumberK052802
Device Name:MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
ClassificationInstrument, Biopsy
Applicant MANAN MEDICAL PRODUCTS, INC. 241 WEST PALATINE RD. Wheeling,  IL  60090
ContactNicohl R Wilding
CorrespondentNicohl R Wilding
MANAN MEDICAL PRODUCTS, INC. 241 WEST PALATINE RD. Wheeling,  IL  60090
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-03
Decision Date2005-11-01
Summary:summary

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