FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONPHAR VELCRO TOUNIGUER
K Number: K803142
·
Decision Jan 13, 1981
Classifications
1
FEI Numbers
335
Registration Numbers
335
Same Product Code
19
Applicant Total
122
Review Days
32
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Basic Information
- Device Name
- CONPHAR VELCRO TOUNIGUER
- K Number
- K803142
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Conphar, Inc.
- Date Received
- December 12, 1980
- Decision Date
- January 13, 1981
- 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
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TOURNIQUET
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STERILE ESMARCH BANDAGE
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DEGANIA SILICONE TOURNIQUET
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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 Conphar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821825 | CONPHAR SILICONE FEEDING TUBE | Aug 10, 1982 | Substantially Equivalent |
| K821295 | OLSEN HEGAR NEEDLE HOLDERS | Jun 3, 1982 | Substantially Equivalent |
| K821354 | CONPHAR MAYO HEGAR NEEDLE HOLDER | Jun 3, 1982 | Substantially Equivalent |
| K821289 | MAYO-HEGAR NEEDLE HOLDER | Jun 3, 1982 | Substantially Equivalent |
| K821298 | BACKHAUS CLAMP, 3 1/2 | May 28, 1982 | Substantially Equivalent |
| K821285 | SPLINTER FORCEPS 4 1/2 | May 28, 1982 | Substantially Equivalent |
| K821276 | MAYO SCISSOR CURYED 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821275 | MAYO SCISSOR STRAIGHT 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821284 | ADSON FORCEPS 4 3/4 | May 28, 1982 | Substantially Equivalent |
| K821248 | ROCHESTER PEAN FORCEPS | May 28, 1982 | Substantially Equivalent |