FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PUNCH
K Number: K841626
·
Decision Aug 27, 1984
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
0
Applicant Total
13
Review Days
130
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Basic Information
- Device Name
- PUNCH
- K Number
- K841626
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Plastafil, Inc.
- Date Received
- April 19, 1984
- Decision Date
- August 27, 1984
- Product Code
- HXG
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HXG | Tamp | FDA class 1 | Orthopedic |
Other Clearances by Plastafil, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841621 | BACK RADIUS CUTTER | Sep 20, 1984 | Substantially Equivalent |
| K841620 | FRONT RADIUS CUTTER | Sep 20, 1984 | Substantially Equivalent |
| K841617 | STROVER HOOK | Aug 27, 1984 | Substantially Equivalent |
| K841629 | DRILL BIT | Aug 27, 1984 | Substantially Equivalent |
| K841625 | HOOK | Aug 27, 1984 | Substantially Equivalent |
| K841624 | PROBE | Aug 27, 1984 | Substantially Equivalent |
| K841618 | THREADING TUBE | Aug 27, 1984 | Substantially Equivalent |
| K841627 | MALLET | Aug 27, 1984 | Substantially Equivalent |
| K841628 | WIRE | Jul 23, 1984 | Substantially Equivalent |
| K841622 | SOFT-TISSUE INSTRUMENT | Jul 11, 1984 | Substantially Equivalent |