510(k) K780255
K780255 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "NEEDLE DRIVER". The FDA issued a decision of Substantially Equivalent on April 18, 1978. The device falls under product code GFC (Driver, Surgical, Pin), a Class I device regulated under 21 CFR 878.4820. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1978
- Date Received
- February 16, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Surgical, Pin
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type