LUMBAR PUNCTURE KIT
FDA 510(k) clearance K970287 · decided 1997-04-07
Clearance details
- K-number
- K970287
- Device name
- LUMBAR PUNCTURE KIT
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-24
- Decision date
- 1997-04-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- FMJ
- Device class
- 2
- Regulation number
- 880.2500
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Spinal Manometer NRFit; Spinal Manometer LUER (K170305) | PAJUNK GmbH Medizintechnologie | 2017-07-25 |
| BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (K032432) | Busse Hospital Disposables, Inc. | 2003-08-28 |
| SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (K963570) | Smiths Industries Medical Systems, Inc. | 1996-10-18 |
| MEGA LUMBAR PUNCTURE KIT (K910089) | Megadyne Medical Products, Inc. | 1991-06-20 |
| HYPODERMIC NEEDLE SHEATH HOLDER (K882405) | Ansr Ent., Inc. | 1988-06-29 |
Recalls involving this device
No recalls on record reference this clearance.