MODIFIED SERIES 2100 ENDOSCOPES

Mini Endoscope, Gastroenterology-urology

MEDICAL LASER, INC.

The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Modified Series 2100 Endoscopes.

Pre-market Notification Details

Device IDK912089
510k NumberK912089
Device Name:MODIFIED SERIES 2100 ENDOSCOPES
ClassificationMini Endoscope, Gastroenterology-urology
Applicant MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis,  MN  55447
ContactGregory J Mathison
CorrespondentGregory J Mathison
MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis,  MN  55447
Product CodeODF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-13
Decision Date1991-08-12

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