510(k) K911913
K911913 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "PRECISION GLIDE - ENHANCED SURGICAL BLADE". The FDA issued a decision of Substantially Equivalent on May 13, 1991. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1991
- Date Received
- April 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Scalpel
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type