Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
FDA 510(k) clearance K150524 · decided 2015-12-16
Clearance details
- K-number
- K150524
- Device name
- Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
- Applicant
- Surgical Instrument Services and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-02
- Decision date
- 2015-12-16
- Days to decision
- 289 days
- Clearance type
- Traditional
- Product code
- NLQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.