NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER

Arthroscope

SURGICAL DYNAMICS, INC.

The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Nucleotome(r) Ii (version2) Tissue Aspira/cutter.

Pre-market Notification Details

Device IDK914282
510k NumberK914282
Device Name:NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER
ClassificationArthroscope
Applicant SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda,  CA  94501
ContactBrad Hutting
CorrespondentBrad Hutting
SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda,  CA  94501
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-24
Decision Date1991-12-19

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