510(k) K770163
K770163 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "SUTURE CUTTER". The FDA issued a decision of Substantially Equivalent on March 30, 1977. The device falls under product code JOK (Scissors, Medical, Disposable), a Class I device regulated under 21 CFR 880.6820. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1977
- Date Received
- January 25, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scissors, Medical, Disposable
- Device Class
- Class I
- Regulation Number
- 880.6820
- Review Panel
- HO
- Submission Type