MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER

Curette, Suction, Endometrial (and Accessories)

MEDSCAND (USA), INC.

The following data is part of a premarket notification filed by Medscand (usa), Inc. with the FDA for Medscand Endorette Endometrial Sampler.

Pre-market Notification Details

Device IDK952652
510k NumberK952652
Device Name:MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
ClassificationCurette, Suction, Endometrial (and Accessories)
Applicant MEDSCAND (USA), INC. P.O. BOX 7733 Hollywood,  FL  33081
ContactTenny P Tse
CorrespondentTenny P Tse
MEDSCAND (USA), INC. P.O. BOX 7733 Hollywood,  FL  33081
Product CodeHHK  
CFR Regulation Number884.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-09
Decision Date1995-09-15

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