MICRO CAUTERY NEEDLES
FDA 510(k) clearance K891400 · decided 1989-04-06
Clearance details
- K-number
- K891400
- Device name
- MICRO CAUTERY NEEDLES
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-14
- Decision date
- 1989-04-06
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- JOS
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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.