FERRIS POLYMEM STERILE BREAST PAD
FDA 510(k) clearance K031660 · decided 2005-02-22
Clearance details
- K-number
- K031660
- Device name
- FERRIS POLYMEM STERILE BREAST PAD
- Applicant
- Ferris Mfg. Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-28
- Decision date
- 2005-02-22
- Days to decision
- 636 days
- Clearance type
- Traditional
- Product code
- NTX
- Device class
- 1
- Regulation number
- 880.5630
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Burr Ridge, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.