PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE
FDA 510(k) clearance K882793 · decided 1988-07-18
Clearance details
- K-number
- K882793
- Device name
- PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE
- Applicant
- Pmt Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-06
- Decision date
- 1988-07-18
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- GAF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chanhassen, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (K023688) | LeMaitre Vascular, Inc. | 2003-01-30 |
| SNAP RECIPROCATING SAW (K935357) | Surgiquip, Inc. | 1994-01-28 |
| ABDOMINAL SPATULA (K890374) | Kinetic Medical Products | 1989-02-03 |
| CEMENT-PICK (K822108) | Bio-Blitz, Inc. | 1982-08-11 |
Recalls involving this device
No recalls on record reference this clearance.