DISTENTION INSTRUMENT, MODIFICATION

Laparoscope, General & Plastic Surgery

ORIGIN MEDSYSTEMS, INC.

The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Distention Instrument, Modification.

Pre-market Notification Details

Device IDK934134
510k NumberK934134
Device Name:DISTENTION INSTRUMENT, MODIFICATION
ClassificationLaparoscope, General & Plastic Surgery
Applicant ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park,  CA  94025
ContactJill Schweiger
CorrespondentJill Schweiger
ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park,  CA  94025
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-18
Decision Date1993-10-05

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