DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]

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 Duo Balloon System (dbs) 1[10 And 12 Mm Sizes].

Pre-market Notification Details

Device IDK954175
510k NumberK954175
Device Name:DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]
ClassificationLaparoscope, General & Plastic Surgery
Applicant ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park,  CA  94025
ContactRichard D Rush
CorrespondentRichard D Rush
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 Received1995-09-05
Decision Date1995-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521068039 K954175 000
20884521068022 K954175 000

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