CLIP-ON SPACER 20%; 40%; 50%
FDA 510(k) clearance K041084 · decided 2004-07-15
Clearance details
- K-number
- K041084
- Device name
- CLIP-ON SPACER 20%; 40%; 50%
- Applicant
- Serono, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-26
- Decision date
- 2004-07-15
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rockland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.