FDA.report

510(k) K936011

Device
INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM
Applicant
INVAMED, INC.
510(k) number
K936011
Product code
HET  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-21
Date received
1993-12-16
Regulation
884.1720
Classification name
Laparoscope, Gynecologic (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
PHIL WOLF
Address
11202 Forest Rain San Antonio TX US 78233 78233

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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