EPIDURAL NEEDLE
FDA 510(k) clearance K980536 · decided 1998-07-31
Clearance details
- K-number
- K980536
- Device name
- EPIDURAL NEEDLE
- Applicant
- Manan Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-11
- Decision date
- 1998-07-31
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.