510(k) K830745
K830745 is an FDA 510(k) premarket notification submitted by Lab Industries, Inc. for the device "ADT DISPOSABLE SCALPEL W/STAINLESS STEEL". The FDA issued a decision of Substantially Equivalent on Apr 12, 1983. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Lab Industries, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 12, 1983
- Date Received
- Mar 8, 1983
- 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