DISPOSABLE PNEUMOPERITONEUM NEEDLE

Pneumoperitoneum Needle

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Disposable Pneumoperitoneum Needle.

Pre-market Notification Details

Device IDK863330
510k NumberK863330
Device Name:DISPOSABLE PNEUMOPERITONEUM NEEDLE
ClassificationPneumoperitoneum Needle
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactWalter S Hennig
CorrespondentWalter S Hennig
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeFHO  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-19
Decision Date1986-10-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521080812 K863330 000
20884521080802 K863330 000

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