FDA.report

510(k) K911462

Device
SURGICAL TROCAR
Applicant
APPLIED MEDICAL
510(k) number
K911462
Product code
DRC  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-22
Date received
1991-04-03
Regulation
870.1390
Classification name
Trocar
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROBERT W SCHAEFER
Address
93 Nashaway Rd. Bolton MA US 01740 01740

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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