MODIFIED SPACEMAKER SYSTEM

Laparoscope, General & Plastic Surgery

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 Modified Spacemaker System.

Pre-market Notification Details

Device IDK042412
510k NumberK042412
Device Name:MODIFIED SPACEMAKER SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactRenee Alfano
CorrespondentRenee Alfano
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-07
Decision Date2004-09-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521067417 K042412 000
20884521067834 K042412 000
20884521067827 K042412 000
20884521067575 K042412 000

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