HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM

Insufflator, Hysteroscopic

DAVOL, INC., SUB. C.R. BARD, INC.

The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Hydrofloex Hd Hysteroscopic Distention System.

Pre-market Notification Details

Device IDK970078
510k NumberK970078
Device Name:HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
ClassificationInsufflator, Hysteroscopic
Applicant DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston,  RI  02920
ContactRobin M Drago
CorrespondentRobin M Drago
DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston,  RI  02920
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-09
Decision Date1997-12-11
Summary:summary

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