MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
FDA 510(k) clearance K011612 · decided 2001-06-22
Clearance details
- K-number
- K011612
- Device name
- MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
- Applicant
- Hydrocision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-25
- Decision date
- 2001-06-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FQH
- Device class
- 2
- Regulation number
- 880.5475
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hopkonton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.