Punch
FDA 510(k) K841626 · Plastafil, Inc.
510(k) numberK841626
Submission
- Device name
- Punch
- Applicant
- Plastafil, Inc.
Mchenry, IL, US - Received
- April 19, 1984
- Decision date
- August 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXG – Tamp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
More from Plastafil, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841621 | Back Radius CutterHTX · Traditional | 09/20/1984SE |
| K841620 | Front Radius CutterHTX · Traditional | 09/20/1984SE |
| K841629 | Drill BitHTW · Traditional | 08/27/1984SE |
| K841627 | MalletHWA · Traditional | 08/27/1984SE |
| K841625 | HookGAD · Traditional | 08/27/1984SE |
| K841624 | ProbeHRX · Traditional | 08/27/1984SE |
| K841618 | Threading TubeFZX · Traditional | 08/27/1984SE |
| K841617 | Strover HookHCF · Traditional | 08/27/1984SE |
| K841628 | WireHXN · Traditional | 07/23/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | 07/11/1984SE |
Questions and answers
When was Punch cleared by the FDA?
Punch (K841626) received a 510(k) decision of Substantially Equivalent on August 27, 1984, 130 days after the submission was received.
What is the product code of K841626?
The FDA product code is HXG – Tamp, a Class I (low risk) device regulated under 21 CFR 888.4540.