HYSTEROSCOPE

Hysteroscope (and Accessories)

CABOT MEDICAL CORP.

The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Hysteroscope.

Pre-market Notification Details

Device IDK896917
510k NumberK896917
Device Name:HYSTEROSCOPE
ClassificationHysteroscope (and Accessories)
Applicant CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne,  PA  19047
ContactTodd Polk
CorrespondentTodd Polk
CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne,  PA  19047
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-11
Decision Date1990-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925002531 K896917 000

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