510(k) K910896

DISPOSABLE ANESTHESIA BREATHING CIRCUIT by Specialty Packaging Producs, Inc. — Product Code CAI

K910896 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "DISPOSABLE ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on May 8, 1991. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1991
Date Received
March 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
Review Panel
AN
Submission Type