BONE RONGEUNS ENT & RELATED ITEMS
FDA 510(k) clearance K822007 · decided 1982-08-12
Clearance details
- K-number
- K822007
- Device name
- BONE RONGEUNS ENT & RELATED ITEMS
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-08
- Decision date
- 1982-08-12
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JZA
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.