510(k) K823789
K823789 is an FDA 510(k) premarket notification submitted by Orthopaedic Resources Corp. for the device "ELASTIC COMPRESSION ANKLET". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code FQL (Stocking, Medical Support (For General Medical Purposes)), a Class I device regulated under 21 CFR 880.5780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1983
- Date Received
- December 16, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stocking, Medical Support (For General Medical Purposes)
- Device Class
- Class I
- Regulation Number
- 880.5780
- Review Panel
- HO
- Submission Type