FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENERAL SURGICAL FILES
K Number: K844145
·
Decision Nov 20, 1984
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
1
Applicant Total
28
Review Days
28
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Basic Information
- Device Name
- GENERAL SURGICAL FILES
- K Number
- K844145
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Med-Tool, Inc.
- Date Received
- October 23, 1984
- Decision Date
- November 20, 1984
- Product Code
- GEO
- 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 |
|---|---|---|---|
| GEO | File, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEO), ordered by most recent decision date.
View allOther Clearances by Med-Tool, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874357 | TAPERED PUNCH | Nov 23, 1987 | Substantially Equivalent |
| K874356 | PIN PUNCH | Nov 23, 1987 | Substantially Equivalent |
| K874359 | ADJUSTABLE WRENCHES | Nov 23, 1987 | Substantially Equivalent |
| K874358 | COMBINATION WRENCHES | Nov 23, 1987 | Substantially Equivalent |
| K872388 | NAIL SET | Jul 23, 1987 | Substantially Equivalent |
| K872385 | VICE OR BENCH VICE | Jul 16, 1987 | Substantially Equivalent |
| K872387 | STANDARD SCREW DRIVER | Jul 16, 1987 | Substantially Equivalent |
| K872389 | PRECISION SCREW DRIVER SET | Jul 15, 1987 | Substantially Equivalent |
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Jul 2, 1987 | Substantially Equivalent |
| K872386 | C CLAMP | Jul 2, 1987 | Substantially Equivalent |