FDA.report

510(k) K971076

Device
PRIMED SHOE COVERS, PRIMED HEAD COVERS
Applicant
PRIMELINE MEDICAL PRODUCTS, INC.
510(k) number
K971076
Product code
FXP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-13
Date received
1997-03-24
Regulation
878.4040
Classification name
Cover, Shoe, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
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
GUY PLAMONDON
Address
2235-27th Ave., NE Calgary Alberta CA T2E 7M4 T2E 7M4

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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