NEUROSURGICAL DRILLS: STILLE, HUDSON
FDA 510(k) clearance K892531 · decided 1989-05-05
Clearance details
- K-number
- K892531
- Device name
- NEUROSURGICAL DRILLS: STILLE, HUDSON
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-11
- Decision date
- 1989-05-05
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- HBG
- Device class
- 2
- Regulation number
- 882.4300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.