510(k) K792097

DRYDEN BACTERIA FILTER by Dryden Corp. — Product Code CAH

K792097 is an FDA 510(k) premarket notification submitted by Dryden Corp. for the device "DRYDEN BACTERIA FILTER". The FDA issued a decision of Substantially Equivalent on November 13, 1979. 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
November 13, 1979
Date Received
October 18, 1979
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