510(k) K872947
K872947 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "POREX QUALITY PLASTIC SURGERY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on August 21, 1987. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820. Porex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1987
- Date Received
- July 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chisel (Osteotome)
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type