ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.

Curette, Suction, Endometrial (and Accessories)

SMITH KLINE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Aspirator & Probe, Cytology, Endomet..

Pre-market Notification Details

Device IDK772121
510k NumberK772121
Device Name:ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
ClassificationCurette, Suction, Endometrial (and Accessories)
Applicant SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHHK  
CFR Regulation Number884.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-10
Decision Date1977-11-17

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