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#
- 3045752480
- 3027500264
- 9614578
- 3007305128
- 3008216220
- 3006400320
- 3013195449
- 3005037196
- 3022114800
- 3010960892
- 3012480144
- 3016096133
- 3015526862
- 3016426850
- 3008523132
- 2028253
- 3031170295
- 3042129334
- 3006008854
- 3030683078
- 3015727296
- 1063727
- 3014663650
- 3014560743
- 2030775
- 3010694026
- 3015775924
- 1225157
- 3007615436
- 3016872092
- 9616914
- 3017621989
- 3014345255
- 3005083016
- 2242474
- 3005246958
- 3010220187
- 9616933
- 2087423
- 3006609021
- 1058152
- 3027328721
- 1422443
- 3012314549
- 3040389283
- 3008903689
- 3001967835
- 3003893701
- 3013557562
- 3042278063
- 3025308438
- 2110420
- 3023471
- 3031595580
- 3015960622
- 3008364966
- 3007731000
- 3044854651
- 3009303371
- 3013002868
- 3043729627
- 3005033444
- 3017697442
- 3016964847
- 3008114969
- 3016796158
- 3007392395
- 3043009869
- 3016450032
- 3006984702
- 9617759
- 9680104
- 3005023997
- 3021630959
- 3042251612
- 9616494
- 3008298912
- 1417592
- 3014264913
Source Documents#
510(k) summary PDF not indicated by FDA