SHARP CHUTE
FDA 510(k) clearance K091690 · decided 2009-07-28
Clearance details
- K-number
- K091690
- Device name
- SHARP CHUTE
- Applicant
- Heathrow Scientific, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-06-10
- Decision date
- 2009-07-28
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Vernon Hills, IL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.