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#
- 3004995608
- 3017264244
- 3010805190
- 2648727
- 1721504
- 3011611571
- 3018269629
- 3004784770
- 3003902965
- 1649395
- 3014527916
- 3017303999
- 3030067857
- 3022568093
- 3001650535
- 3006554788
- 3015378469
- 8043685
- 2248030
- 3021292112
- 3014620201
- 3008044484
- 3013524663
- 3012330365
- 3009107511
- 3025413691
- 3003803075
- 1043214
- 3005853033
- 3014313732
- 3017805218
- 3011280379
- 3015172365
- 3008808560
- 9616765
- 3017406698
- 3008386507
- 3042244574
- 3015276780
- 3013527364
- 9616086
- 3006056044
- 3004111573
- 3017538679
- 1036781
- 3014437893
- 2032476
- 1528440
- 3001084743
- 1319660
- 1824619
- 3000682787
- 3008918830
- 3010687973
- 3009540516
- 8020040
- 1420054
- 3004551550
- 1250045
- 3003887292
- 3010759902
- 3012777736
- 3014108257
- 3000958046
- 3005034064
- 3011706862
- 9681702
- 3003684315
- 9616916
- 3007648354
- 3018779125
- 1123010
- 3007700294
- 2182303
- 3013187142
- 3004488394
- 3011657181
- 3006750986
- 3015058854
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 |