510(k) K892053

RESPAKIT by Protectical Health & Safety , Ltd. — Product Code CAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1989
Date Received
March 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Oropharyngeal, Anesthesiology
Device Class
Class I
Regulation Number
868.5110
Review Panel
AN
Submission Type