DURALASTIC II
FDA 510(k) clearance K955370 · decided 1996-02-08
Clearance details
- K-number
- K955370
- Device name
- DURALASTIC II
- Applicant
- Allied Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-22
- Decision date
- 1996-02-08
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MIB
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Goose Creek, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.