ENDOSCOPIC INSTRUMENT

Laparoscope, Gynecologic (and Accessories)

EDER INSTRUMENT CO, INC.

The following data is part of a premarket notification filed by Eder Instrument Co, Inc. with the FDA for Endoscopic Instrument.

Pre-market Notification Details

Device IDK791052
510k NumberK791052
Device Name:ENDOSCOPIC INSTRUMENT
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant EDER INSTRUMENT CO, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-06
Decision Date1979-08-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.