510(k) K840205

DRYDEN MINI BACTERIA FILTER by Dryden Corp. — Product Code CAH

K840205 is an FDA 510(k) premarket notification submitted by Dryden Corp. for the device "DRYDEN MINI BACTERIA FILTER". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Dryden Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 19, 1984
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