510(k) K821178
K821178 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "ETHICON EXTERNAL FIXATION WIRE". The FDA issued a decision of Substantially Equivalent on June 11, 1983. The device falls under product code FYI (Appliance, Facial Fracture, External), a Class I device regulated under 21 CFR 878.3250. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1983
- Date Received
- April 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Facial Fracture, External
- Device Class
- Class I
- Regulation Number
- 878.3250
- Review Panel
- SU
- Submission Type