510(k) K962312

KEY CHAIN EMERGENCY AIRWAY by Ffrench Pocket Emergency Airway, Inc. — Product Code BWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1997
Date Received
June 17, 1996
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