LASER LAPARAXOPE

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 Laser Laparaxope.

Pre-market Notification Details

Device IDK831241
510k NumberK831241
Device Name:LASER LAPARAXOPE
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 Received1983-04-15
Decision Date1983-06-10

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