FDA.report

510(k) K770428

Device
VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.
Applicant
HOLCO INSTRUMENT CORP.
510(k) number
K770428
Product code
FSM  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-12
Date received
1977-03-07
Regulation
878.4800
Classification name
Tray, Surgical, Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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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