WALLACH FLEXIBLE ENDOMETRIAL SAMPLER

Aspirator, Endometrial

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Flexible Endometrial Sampler.

Pre-market Notification Details

Device IDK902693
510k NumberK902693
Device Name:WALLACH FLEXIBLE ENDOMETRIAL SAMPLER
ClassificationAspirator, Endometrial
Applicant WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford,  CT  06460
ContactVincent Frazzetta
CorrespondentVincent Frazzetta
WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford,  CT  06460
Product CodeHFF  
CFR Regulation Number884.1060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-19
Decision Date1991-01-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30888937011266 K902693 000
30888937011259 K902693 000
00888937011241 K902693 000

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