FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRAWER TEST
K Number: K812713
·
Decision Nov 5, 1981
Classifications
1
FEI Numbers
398
Registration Numbers
398
Same Product Code
22
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- DRAWER TEST
- K Number
- K812713
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medmetric Corp.
- Date Received
- September 25, 1981
- Decision Date
- November 5, 1981
- Product Code
- FTY
- 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 |
|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Medmetric Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K943197 | KT1000/S KNEE LIGAMENT ARTHROMETER | Mar 2, 1995 | Substantially Equivalent |
| K942059 | KT2000 KNEE LIGAMENT ARTHROMETER | Sep 20, 1994 | Substantially Equivalent |
| K904823 | FLEXERCYCLE | Jan 30, 1991 | Substantially Equivalent |
| K904898 | TORQUE FRAME QTF1000 | Nov 28, 1990 | Substantially Equivalent |
| K854254 | TENSION-ISOMETER | Nov 15, 1985 | Substantially Equivalent |
| K812806 | KT-1000 DEVICE | Nov 10, 1981 | Substantially Equivalent |
| K801572 | SURG-ASSIST | Aug 4, 1980 | Substantially Equivalent |