510(k) K771587

INSTANT AIR by Hyde, Vernon E., D.D.S. — Product Code BWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1977
Date Received
August 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Emergency Airway
Device Class
Class II
Regulation Number
868.5090
Review Panel
AN
Submission Type