FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VELKET TOURNIQUET
K Number: K780594
·
Decision Jun 6, 1978
Classifications
1
FEI Numbers
335
Registration Numbers
335
Same Product Code
19
Applicant Total
127
Review Days
57
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Basic Information
- Device Name
- VELKET TOURNIQUET
- K Number
- K780594
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- April 10, 1978
- Decision Date
- June 6, 1978
- Product Code
- GAX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAX), ordered by most recent decision date.
UNIQUET
FDA 510(k)
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TOURNIQUET
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STERILE ESMARCH BANDAGE
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DEGANIA SILICONE TOURNIQUET
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FDA Class 1
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UNIVERSAL TOURNIQUET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KINDERWRAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Abco Dealers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905025 | DIGITAL THERMOMETER KITS | Feb 7, 1991 | Substantially Equivalent |
| K882304 | DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) | Jul 12, 1988 | Substantially Equivalent |
| K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS | Apr 21, 1988 | Substantially Equivalent |
| K880894 | ALLERGIST SYRINGES | Mar 31, 1988 | Substantially Equivalent |
| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |