510(k) K955520

RESCUE BREATHER by International Safety, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1996
Date Received
December 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type