510(k) K832647
K832647 is an FDA 510(k) premarket notification submitted by Ardent Intl., Inc. for the device "ARTICULATING PAPER". The FDA issued a decision of Substantially Equivalent on Feb 21, 1984. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Ardent Intl., Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 1984
- Date Received
- Aug 5, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Paper, Articulation
- Device Class
- Class I
- Regulation Number
- 872.6140
- Review Panel
- DE
- Submission Type
- 510(k) Exempt