510(k) K864572
K864572 is an FDA 510(k) premarket notification submitted by Prodent Intl., Inc. for the device "FIXTECTOR". The FDA issued a decision of Substantially Equivalent on Feb 12, 1987. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Prodent Intl., Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 1987
- Date Received
- Nov 20, 1986
- 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