510(k) K973829

IRRIGATION BOTTLE by Automatic Liquid Packaging, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1998
Date Received
October 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type