510(k) K881496

LINDER NASOTRACHEAL AIRWAY by Polamedco, Inc. — Product Code BTR

K881496 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "LINDER NASOTRACHEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Polamedco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
April 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type