510(k) K841628
K841628 is an FDA 510(k) premarket notification submitted by Plastafil, Inc. for the device "WIRE". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code HXN (Applier, Cerclage), a Class I device regulated under 21 CFR 888.4540. Plastafil, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1984
- Date Received
- April 19, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Cerclage
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type