ENDOPATH VERESS NEEDLE

Needle, Pneumoperitoneum, Simple

SYMBIOSIS CORP.

The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Endopath Veress Needle.

Pre-market Notification Details

Device IDK910855
510k NumberK910855
Device Name:ENDOPATH VERESS NEEDLE
ClassificationNeedle, Pneumoperitoneum, Simple
Applicant SYMBIOSIS CORP. 5801 MIAMI LAKES DR. Miami Lakes,  FL  33014
ContactKevin Smith
CorrespondentKevin Smith
SYMBIOSIS CORP. 5801 MIAMI LAKES DR. Miami Lakes,  FL  33014
Product CodeFHP  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-28
Decision Date1991-04-18

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