UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
FDA 510(k) clearance K843282 · decided 1984-10-22
Clearance details
- K-number
- K843282
- Device name
- UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
- Applicant
- Rush Hampton Industries
- Decision
- Substantially Equivalent
- Date received
- 1984-08-20
- Decision date
- 1984-10-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- BWH
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Sanford, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.