C-LEG (3C100)— 510(k) K991590
Substantially EquivalentOtto Bock Orthopedic Industry, Inc.
FDA 510(k) clearance K991590 for C-LEG (3C100), Substantially Equivalent on 1999-07-08. Applicant: Otto Bock Orthopedic Industry, Inc.. Device class: 2.
Clearance details
- Applicant
- Otto Bock Orthopedic Industry, Inc.
- Product code
- Code ISW
- Device class
- Class 2
- Regulation
- 21 CFR 890.3500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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