FDA.report

510(k) K984600

Device
METRA PS PROCEDURE KIT
Applicant
INLET MEDICAL, INC.
510(k) number
K984600
Product code
GCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-03
Date received
1998-12-28
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARK STERRETT
Address
2400 Crittenden Dr. Louisville KY US 40217 40217

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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