510(k) K782046
K782046 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "C-CORD". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code FFZ (Cord, Electric, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1979
- Date Received
- December 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Electric, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type