STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
FDA 510(k) clearance K013059 · decided 2001-10-22
Clearance details
- K-number
- K013059
- Device name
- STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
- Applicant
- Stony Brook Surgical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-11
- Decision date
- 2001-10-22
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GAQ
- Device class
- 2
- Regulation number
- 878.4495
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.