510(k) K930730
- Device
- Dormie Neck Support System
- Applicant
- THE WESTERN DIAGNOSTICS CO.
- 510(k) number
- K930730
- Product code
- IQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-22
- Date received
- 1993-02-11
- Regulation
- 890.3490
- Classification name
- Orthosis, Cervical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC S SIEGEL
- Address
- 2617a Okeechobee Blvd. West Palm Beach FL US 33409 33409
FDA Registration Numbers#
- 1000357070
- 3010260768
- 3003778929
- 3017619379
- 1058152
- 1528759
- 3007853907
- 3010097171
- 3003887292
- 3005273623
- 3008381107
- 3004713344
- 1054236
- 3023809973
- 3013527364
- 1824252
- 3006227741
- 3010515776
- 3005157379
- 3010987649
- 3009273990
- 3014896622
- 3011767724
- 3033918960
- 3033519
- 3014672091
- 3016515429
- 3031583032
- 3010123014
- 9611956
- 3007123908
- 3007076137
- 3005846457
- 3008523132
- 3016964847
- 3030539818
- 3015526862
- 3014658541
- 3027500264
- 3006266055
- 3004161950
- 1527105
- 3011919098
- 3010409218
- 3006085220
- 3022549
- 3015416207
- 9616086
- 3014847663
- 3018503755
- 3017264244
- 2530195
- 3016450032
- 3009131011
- 3004129296
- 3004777506
- 3030522263
- 3005532347
- 3016678950
- 3018269545
- 3003924186
- 3013522894
- 3015214304
- 3010960892
- 3035878914
- 1836161
- 3012316249
- 1526439
- 3005885000
- 3006336810
- 3005023997
- 3020978012
- 3013735117
- 3003855936
- 3010097863
- 3008048783
- 1038963
- 3007774549
- 3010703418
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IQK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 |