510(k) K810450
- Device
- Truncal Orthosis
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K810450
- Product code
- IQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-04
- Date received
- 1981-02-19
- Regulation
- 890.3490
- Classification name
- Orthosis, Lumbar
- 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#
- 3008216220
- 3013557562
- 3031606416
- 3013545943
- 3013857401
- 1038963
- 9616914
- 3005033444
- 8010507
- 3013957847
- 3005748172
- 3011786430
- 1000357070
- 3000297887
- 3011287176
- 3012841710
- 3010960892
- 3015960622
- 3008724689
- 3017633586
- 3014345255
- 3015526862
- 3014204518
- 3034241144
- 3031595580
- 3009834955
- 3015543909
- 3011240418
- 3009118610
- 3044854651
- 3006008854
- 3009068676
- 3017638051
- 1054236
- 3017910381
- 3014301596
- 8010100
- 3016450032
- 9616933
- 3042251612
- 3010834934
- 3011678115
- 3015337144
- 2530195
- 3026309274
- 9614578
- 3008363392
- 3033436414
- 3030683078
- 3006609021
- 3017417635
- 3015989868
- 3024104912
- 3014658541
- 3037609256
- 3016680721
- 3025114926
- 1417592
- 1422443
- 3013770567
- 3007109661
- 3021282525
- 3008412545
- 3015069144
- 3017621989
- 3005951403
- 1225157
- 3007222552
- 3004096515
- 3008247697
- 3023212654
- 3015429713
- 3027500264
- 3026020435
- 3005846457
- 3013198248
- 3011789046
- 3012494290
- 3008008970
Source Documents#
510(k) summary PDF not indicated by FDA