510(k) K780617
- Device
- Equalizer
- Applicant
- BALLERT ORTHOPEDIC CORP.
- 510(k) number
- K780617
- Product code
- IPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-18
- Date received
- 1978-04-13
- Regulation
- 890.3025
- Classification name
- Shoe, Cast
- 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#
- 3017264244
- 3007125287
- 3009118610
- 3007123908
- 2028253
- 8022890
- 1060680
- 3010595915
- 3021394836
- 3033858295
- 1026765
- 8031020
- 1057079
- 3003764610
- 3009009512
- 3006266055
- 3003890514
- 3016444419
- 3010694026
- 3027500264
- 2530195
- 3010703418
- 3004179819
- 3015069144
- 3007127364
- 3014982318
- 1054236
- 3016147813
- 2242467
- 3006619688
- 3003829642
- 3010260768
- 3008395114
- 3005663580
- 3008247697
- 3008146511
- 3042251628
- 3009308092
- 3013557562
- 3014658541
- 1043214
- 2030775
- 3010785927
- 3004161950
- 3010033845
- 3003855936
- 3033796310
- 3006943846
- 3007207474
- 3006227741
- 3004905643
- 3015459201
- 1417592
- 3010309201
- 3005037196
- 1422443
- 2028810
- 3015134013
- 3010388474
- 3013657868
- 3042871597
- 1122845
- 9680104
- 3003893701
- 2182345
- 8022755
- 2183988
- 3013180212
- 3043009869
- 3012281713
- 3007109661
- 3031027442
- 3006897996
- 1523547
- 3012480144
- 9611956
- 3017297225
- 3013515242
- 2950684
- 3012026312
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K024279 | NESS CHILDREN SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | 2003-02-05 |
| K790652 | TOGUARD | Togard, Inc. | 1979-04-04 |
| K781363 | CAST SHOE | Cutler Biomedical | 1978-08-14 |
| K760575 | ROCKER-SOLE CAST SANDAL | Richard'S Medical Equip., Inc. | 1976-10-06 |
| K760578 | BALANCED CAST SOLE | Parke-Davis Co. | 1976-09-27 |