510(k) K822896
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