510(k) K925505

RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE by Rusch, Inc. — Product Code BTR

K925505 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE". The FDA issued a decision of Substantially Equivalent on September 2, 1993. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Rusch, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1993
Date Received
October 30, 1992
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