POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
FDA 510(k) clearance K022665 · decided 2002-10-09
Clearance details
- K-number
- K022665
- Device name
- POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
- Applicant
- Hohenstein Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-09
- Decision date
- 2002-10-09
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- KKY
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.