510(k) K871263

MULTIPLE PHARMA-PLAST TRACHEAL TUBE by Pharma-Plast USA, Inc. — Product Code BTR

K871263 is an FDA 510(k) premarket notification submitted by Pharma-Plast USA, Inc. for the device "MULTIPLE PHARMA-PLAST TRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on June 15, 1987. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Pharma-Plast USA, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1987
Date Received
March 31, 1987
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