510(k) K810024
- Device
- Bonner Brace
- Applicant
- BEE ENT.
- 510(k) number
- K810024
- Product code
- IQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-01-23
- Date received
- 1981-01-05
- Regulation
- 890.3490
- Classification name
- Orthosis, Cervical
- 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#
- 8010658
- 3006755899
- 3005951403
- 3011767724
- 3011556461
- 1043591
- 3010452651
- 3020978012
- 3008114965
- 9614578
- 8030607
- 3007109661
- 3044707950
- 3017297225
- 3014345255
- 3013564290
- 3010101089
- 9680668
- 3011181154
- 3045058049
- 3005083016
- 3006891384
- 3005282622
- 3009009512
- 1824252
- 3030683078
- 1643116
- 3024755175
- 3007774549
- 3013875443
- 2031918
- 3014060494
- 3015142701
- 1057079
- 3014663650
- 3033849261
- 3030630899
- 1058152
- 3017417635
- 3031595580
- 3007076137
- 1523574
- 3008410069
- 2110898
- 3010694026
- 3011706862
- 3021282525
- 3004824601
- 3007731000
- 3007207474
- 3008808082
- 3013002868
- 3003902312
- 2135152
- 3002404380
- 3006227741
- 3005663580
- 3013735117
- 3013070831
- 3013770567
- 3015960622
- 3011191255
- 2182979
- 3005157379
- 3014896622
- 3005621729
- 3010987649
- 3009131011
- 3013515242
- 3015526491
- 3005037196
- 3010097171
- 3005273623
- 3003855936
- 3008381107
- 3004129296
- 3015416207
- 3039396083
- 3006803543
- 1422443
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IQK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930730 | DORMIE NECK SUPPORT SYSTEM | The Western Diagnostics Co. | 1993-07-22 |
| K926291 | SCHUL-TEC IMMOBILIZER | Medical Emergency Support Equipment | 1993-03-30 |
| K895477 | NOVA PILLOW | Nova Health Systems, Inc. | 1990-01-10 |
| K896042 | MEDICAL DISPOSABLE BEDDING | Keystone Veterinary Supplies, Inc. | 1990-01-10 |
| K882264 | BATTLE CREEK PILLOW | Battle Creek Equipment Co. | 1988-08-09 |
| K850465 | CERVICAL COLLARS & HEAD HALTERS | Abco Dealers, Inc. | 1985-04-25 |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Laerdal California, Inc. | 1983-11-07 |
| K832001 | HEAD-IMMOBILIZER | Int'L Safety Corp. | 1983-07-12 |
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1983-06-15 |
| K830348 | VINYL EXTRICATION COLLAR | Deip Enterprises, Inc. | 1983-03-09 |
| K830350 | CERVICAL PILLOW | Deip Enterprises, Inc. | 1983-03-09 |
| K830351 | DISPOSABLE EXTRICATION COLLAR | Deip Enterprises, Inc. | 1983-03-09 |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823247 | U-WAY QUICKOLLAR | Ems Industries, Inc. | 1982-11-16 |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-11-10 |