510(k) K834168
K834168 is an FDA 510(k) premarket notification submitted by Canberra Industries, Inc. for the device "FIBRINOGEN UPTAKE SYS -VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code JZD (Snare, Ear), a Class I device regulated under 21 CFR 874.4420. Canberra Industries, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1983
- Date Received
- November 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type