IUR RECIPROCATING MORCELLATOR MODEL # 7210517

Hysteroscope (and Accessories)

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Iur Reciprocating Morcellator Model # 7210517.

Pre-market Notification Details

Device IDK041774
510k NumberK041774
Device Name:IUR RECIPROCATING MORCELLATOR MODEL # 7210517
ClassificationHysteroscope (and Accessories)
Applicant SMITH & NEPHEW, INC. 150 Minuteman Road Andover,  MA  01810
ContactJanice Haselton
CorrespondentJanice Haselton
SMITH & NEPHEW, INC. 150 Minuteman Road Andover,  MA  01810
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-01
Decision Date2004-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885554027617 K041774 000

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