510(k) K770558
- Device
- ISODYNE
- Applicant
- Hmw Industries
- 510(k) number
- K770558
- Product code
- ECO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-05
- Date received
- 1977-03-22
- Regulation
- 872.5410
- Classification name
- Spring, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005014825
- 3008323540
- 3008882689
- 3043149181
- 2024980
- 3005027553
- 3009438612
- 9680845
- 3022296393
- 3015436889
- 3004730002
- 1000118628
- 3007962015
- 3007284437
- 3007616048
- 3015136927
- 3003971538
- 3004201548
- 3003850991
- 3030531648
- 3015337428
- 3001561923
- 1293141
- 3006034256
- 3034693059
- 3014827340
- 3015259864
- 1815540
- 3035708505
- 3014270297
- 8010342
- 3004704962
- 3003622434
- 3009955691
- 3009257060
- 3012477813
- 1937100
- 3027157163
- 3005663302
- 2126683
- 3012421607
- 3010065389
- 1221844
- 3008524225
- 3034603709
- 3004645512
- 1718476
- 3017912663
- 3010032042
- 3013561919
- 3013641573
- 2081322
- 3014683120
- 3013508670
- 3009827000
- 3005256634
- 3013519244
- 3009011037
- 3015272949
- 3006237499
- 3009171220
- 9681207
- 3030680214
- 3005515228
- 9611458
- 1222301
- 3043648115
- 3016543896
- 3017953780
- 9710113
- 3027520354
- 3008005217
- 3011554142
- 3013689189
- 3006621310
- 3032163716
- 8044058
- 3014253211
- 1833132
- 3007728269
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ECO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943068 | MAGNEFORCE | Ormco Corp. | 1994-08-17 |
| K933542 | MESIAL LOOP BAR | Gac Intl., Inc. | 1994-08-05 |
| K942492 | ADJUSTABLE BITE CORRECTOR | Orthoplus, Inc. | 1994-07-13 |
| K844234 | ACTIVE VERTICAL CORRECTOR APPLIANCE | Active Vertical Correctors, Inc. | 1985-01-04 |
| K843550 | ORTHOMAG MAGNETIC FORCE SYSTEM | Medical Magnetics, Inc. | 1984-12-21 |
| K843344 | ACTIVE VERTICAL CORRECTOR ACTIVE BITE | Active Vertical Correctors, Inc. | 1984-12-03 |