510(k) K851452
K851452 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "VALTRAC PURSESTING DEVICE". The FDA issued a decision of Substantially Equivalent on June 12, 1985. The device falls under product code HCF (Instrument, Ligature Passing And Knot Tying), a Class I device regulated under 21 CFR 878.4800. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 1985
- Date Received
- April 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ligature Passing And Knot Tying
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type