I-STOP
FDA 510(k) clearance K051533 · decided 2005-08-11
Clearance details
- K-number
- K051533
- Device name
- I-STOP
- Applicant
- Cl Medical
- Decision
- Substantially Equivalent
- Date received
- 2005-06-09
- Decision date
- 2005-08-11
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sainte Foy Les Lyon, FR
- 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.