KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
FDA 510(k) clearance K070360 · decided 2007-08-07
Clearance details
- K-number
- K070360
- Device name
- KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
- Applicant
- Kirwan Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-07
- Decision date
- 2007-08-07
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Marshfield, MA, 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.
Recalls involving this device
No recalls on record reference this clearance.