510(k) K780594
- Device
- Velket Tourniquet
- Applicant
- ABCO DEALERS, INC.
- 510(k) number
- K780594
- Product code
- GAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-06-06
- Date received
- 1978-04-10
- Regulation
- 878.5900
- Classification name
- Tourniquet, Nonpneumatic
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- 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#
- 3022568093
- 3015821396
- 2245304
- 3008918830
- 3006410968
- 1422443
- 3009056984
- 3014313732
- 1060680
- 3005034064
- 3010187802
- 3011427127
- 3010687973
- 1832653
- 3003902965
- 2321034
- 3010131137
- 3011209798
- 3015173212
- 2030624
- 3008449424
- 3008044484
- 1724474
- 3004519921
- 3012137459
- 3033589330
- 2182303
- 9680836
- 3003965134
- 3035597675
- 3010380285
- 1649395
- 3016661562
- 3013632692
- 1820334
- 3015058854
- 3003895930
- 3006191977
- 3009605245
- 3009486864
- 3010967704
- 3005012805
- 3008770063
- 3011642792
- 3013557562
- 3007006186
- 3011983031
- 3023339256
- 3004720500
- 3009746061
- 3015173437
- 1417592
- 3017155466
- 3007439125
- 1835458
- 1932015
- 3023809973
- 3030067857
- 3004488394
- 8020040
- 3007703436
- 3010410654
- 3006897996
- 1721504
- 3040389256
- 3003546412
- 3006950086
- 3004784770
- 3015140199
- 3024453223
- 3018296902
- 3020978037
- 3004417597
- 3011706862
- 3012314549
- 3015474594
- 3005853033
- 8030107
- 3006750986
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931198 | UNIQUET | Icat Systems | 1993-09-01 |
| K881398 | TOURNIQUET | Barretta Products, Research and Development, Inc. | 1988-04-29 |
| K881176 | STERILE ESMARCH BANDAGE | Spectrum/Hydro-Med Products, Inc. | 1988-04-11 |
| K875092 | DEGANIA SILICONE TOURNIQUET | Degania Silicone , Ltd. | 1988-01-07 |
| K873928 | UNIVERSAL TOURNIQUET | Dryden Corp. | 1987-10-23 |
| K872003 | KINDERWRAP | The Kinder Co. | 1987-06-23 |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Dale Medical Products, Inc. | 1987-01-12 |
| K853472 | FINGER TOURNIQUETTE | Joseph B. Marogil | 1985-10-10 |
| K853537 | VELCRO TOURNIQUET | Cp Medical | 1985-09-12 |
| K852277 | CATAPRESS TOURNIGUET | Boehringer Ingelheim Pharmaceuticals, Inc. | 1985-06-27 |
| K851482 | TOURNIQUET | Polymer Technology Corp. | 1985-04-29 |
| K843056 | ELASTIC BANDAGE | Sterile Medical Systems | 1984-12-04 |
| K840489 | DISPOSIQUET A DISPOS. TOURNIQUET | Med Lab Products | 1984-03-12 |
| K830467 | TOURNIQUET/LATEX TOURNIQUET | Primeline Industries, Inc. | 1983-03-31 |
| K822553 | PRESSURE-QUET TOURNIQUET | Nutec Med, Inc. | 1982-09-17 |