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#
- 3017264244
- 3034205725
- 3008466086
- 3015960622
- 3006336810
- 3014847663
- 3023158731
- 3003764610
- 1051118
- 3016591678
- 3008410069
- 3045075631
- 3007289408
- 3010260768
- 3017621989
- 3004727093
- 3033796310
- 3016707060
- 8010507
- 3013180212
- 1043214
- 3007109661
- 3040389283
- 3039396083
- 3013564290
- 3005621729
- 3014896622
- 3014982318
- 9616914
- 3008808082
- 3009009512
- 3005846457
- 2028253
- 3045030500
- 3006227741
- 3005532347
- 3004096515
- 1063727
- 9681385
- 3008903689
- 3009759525
- 3013527364
- 9616086
- 3008146511
- 1643116
- 3014658541
- 3007774549
- 3010453133
- 3010239526
- 3010371670
- 3021282525
- 1043591
- 3003890514
- 3033790380
- 1641302
- 1043533
- 3030683078
- 3003887292
- 3012777736
- 3005033444
- 9617759
- 3011706862
- 2242467
- 1016498
- 3007731000
- 2182345
- 3018269545
- 3010033845
- 3030522263
- 3030539818
- 3006400320
- 3008381107
- 3011919098
- 3022549
- 3011657181
- 3006750986
- 2135152
- 1057079
- 3043009869
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 |