510(k) K991590
K991590 is an FDA 510(k) premarket notification submitted by Otto Bock Orthopedic Industry, Inc. for the device "C-LEG (3C100)". The FDA issued a decision of Substantially Equivalent on July 8, 1999. The device falls under product code ISW (Assembly, Knee/Shank/Ankle/Foot, External), a Class II device regulated under 21 CFR 890.3500. Otto Bock Orthopedic Industry, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1999
- Date Received
- May 7, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assembly, Knee/Shank/Ankle/Foot, External
- Device Class
- Class II
- Regulation Number
- 890.3500
- Review Panel
- PM
- Submission Type