510(k) K770425

NEEDLES, STERILE, AIRWAY by Pfizer Pharmaceuticals — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
March 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type