Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
FDA 510(k) clearance K143252 · decided 2015-04-23
Clearance details
- K-number
- K143252
- Device name
- Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
- Applicant
- Needle Tech Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-13
- Decision date
- 2015-04-23
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.