510(k) K991590
- Device
- C-LEG (3C100)
- Applicant
- OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
- 510(k) number
- K991590
- Product code
- ISW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-07-08
- Date received
- 1999-05-07
- Regulation
- 890.3500
- Classification name
- Assembly, Knee/shank/ankle/foot, External
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN HENDRICKSON
- Address
- 3000 Xenium Ln., Suite N Plymouth MN US 55441 55441
FDA Registration Numbers#
- 3014827594
- 3010220187
- 3008584163
- 1721652
- 3007123908
- 3003855936
- 3006943846
- 3004737223
- 3004134478
- 3027645766
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases