PMT Fukushima Microsurgical Instrument Line
FDA 510(k) K882793 · Pmt Corp.
510(k) numberK882793
Submission
- Device name
- PMT Fukushima Microsurgical Instrument Line
- Applicant
- Pmt Corp.
Chanhassen, MN, US - Received
- July 6, 1988
- Decision date
- July 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAF – Spatula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K890374 | Abdominal SpatulaGAF · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K822108 | Cement-PickGAF · Traditional | Bio-Blitz, Inc. | 08/11/1982SE |
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Questions and answers
When was PMT Fukushima Microsurgical Instrument Line cleared by the FDA?
PMT Fukushima Microsurgical Instrument Line (K882793) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 12 days after the submission was received.
What is the product code of K882793?
The FDA product code is GAF – Spatula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.