510(k) K821256
- Device
- Counter-rotation System
- Applicant
- THE LANGER GROUP
- 510(k) number
- K821256
- Product code
- ITN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-23
- Date received
- 1982-04-30
- Regulation
- 890.3675
- Classification name
- Splint, Denis Brown
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013680140
- 3003898328
- 8040278
- 3000146561
- 3011564321
- 3011658802
- 1051118
- 1058152
- 3011497619
- 1022826
- 2950684
- 1824252
- 3005841961
- 3005663580
Source Documents#
510(k) summary PDF not indicated by FDA