510(k) K922492

SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER by Specialty Packaging Producs, Inc. — Product Code CAH

K922492 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER". The FDA issued a decision of Substantially Equivalent on August 24, 1992. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
May 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type