FOAM RING PORT PROTECTOR
FDA 510(k) clearance K062261 · decided 2007-04-09
Clearance details
- K-number
- K062261
- Device name
- FOAM RING PORT PROTECTOR
- Applicant
- Inspired Ideas, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2006-08-04
- Decision date
- 2007-04-09
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- OBK
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carmel, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.