510(k) K850423
K850423 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "CONCEPT SUCTION SLEEVE". The FDA issued a decision of Substantially Equivalent on March 14, 1985. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1985
- Date Received
- February 4, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Cutting, Orthopedic
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type