K820291 is an FDA 510(k) clearance for the KNEE SUPPORT FOR X-RAY & SURGERY. This device is classified as a Operating Room Accessories Table Tray (Class I - General Controls, product code FWZ).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982, 30 days after receiving the submission on February 3, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance..
| 510(k) Number | K820291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1982 |
| Decision Date | March 05, 1982 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FWZ — Operating Room Accessories Table Tray |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |