CONTACT-MICRO COLPOHYSTEROSCOPE

Hysteroscope (and Accessories)

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Contact-micro Colpohysteroscope.

Pre-market Notification Details

Device IDK810569
510k NumberK810569
Device Name:CONTACT-MICRO COLPOHYSTEROSCOPE
ClassificationHysteroscope (and Accessories)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-03
Decision Date1981-07-16

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