510(k) K822896

CAVIDRY by Parker Laboratories, Inc. — Product Code EJH

K822896 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "CAVIDRY". The FDA issued a decision of Substantially Equivalent on October 22, 1982. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1982
Date Received
September 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type