510(k) K821639
K821639 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "ANKLE FOOT ORTHOSIS". The FDA issued a decision of Substantially Equivalent on June 11, 1982. The device falls under product code ITW (Joint, Ankle, External Brace), a Class I device regulated under 21 CFR 890.3475. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1982
- Date Received
- June 3, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Joint, Ankle, External Brace
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type