RESECTOSCOPE SAFETY SHEATH

Hysteroscope (and Accessories)

CONCEPTUS, INC.

The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Resectoscope Safety Sheath.

Pre-market Notification Details

Device IDK972210
510k NumberK972210
Device Name:RESECTOSCOPE SAFETY SHEATH
ClassificationHysteroscope (and Accessories)
Applicant CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos,  CA  94070
ContactCindy Domecus
CorrespondentCindy Domecus
CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos,  CA  94070
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-11
Decision Date1997-09-05
Summary:summary

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