TRAUS SIP10
FDA 510(k) clearance K123695 · decided 2012-12-18
Clearance details
- K-number
- K123695
- Device name
- TRAUS SIP10
- Applicant
- Saeshin Precision Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-03
- Decision date
- 2012-12-18
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- EKY
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Daegu, KR
- Third-party review
- Yes
- 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 |
|---|---|---|
| DECIDENT (K896364) | Nevin Laboratories, Inc. | 1990-07-19 |
Recalls involving this device
No recalls on record reference this clearance.