MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
FDA 510(k) clearance K032721 · decided 2003-10-06
Clearance details
- K-number
- K032721
- Device name
- MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
- Applicant
- Stellartech Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-03
- Decision date
- 2003-10-06
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.