510(k) K822749
K822749 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PILLING DIAMOND KNIFE". The FDA issued a decision of Substantially Equivalent on Oct 6, 1982. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Narco Scientific has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 1982
- Date Received
- Sep 10, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Scalpel, One-Piece
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt