ELLIPSE PUNCH
FDA 510(k) clearance K904869 · decided 1991-03-06
Clearance details
- K-number
- K904869
- Device name
- ELLIPSE PUNCH
- Applicant
- Kramer Const
- Decision
- Substantially Equivalent
- Date received
- 1990-10-29
- Decision date
- 1991-03-06
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- LRY
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palo Alto, CA, 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 |
|---|---|---|
| ACU-E PUNCH (K933516) | Acuderm, Inc. | 1994-03-24 |
| LIPOGEN RHEUMELISA DSDNA ASSAY (K902636) | Lipogen, Inc. | 1990-06-28 |
| BIOPSY PUNCH (K896303) | Premier Medical | 1990-02-13 |
| PIN PUNCH (K874356) | Med-Tool, Inc. | 1987-11-23 |
| TAPERED PUNCH (K874357) | Med-Tool, Inc. | 1987-11-23 |
| NAIL SET (K872388) | Med-Tool, Inc. | 1987-07-23 |
Recalls involving this device
No recalls on record reference this clearance.