510(k) K910089
- Device
- MEGA LUMBAR PUNCTURE KIT
- Applicant
- MEGADYNE MEDICAL PRODUCTS, INC.
- 510(k) number
- K910089
- Product code
- FMJ
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1991-06-20
- Date received
- 1991-01-09
- Regulation
- 880.2500
- Classification name
- Manometer, Spinal-fluid
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELLEN JOY
- Address
- P.O.Box 260956 Tampa FL US 33685 33685
FDA Registration Numbers#
- 3009750712
- 2521402
- 2433012
- 2011171
- 1921846
- 3013764800
- 2523676
- 1423537
- 9611612
- 1319639
- 2029015
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | 2017-07-25 |
| K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | Busse Hospital Disposables, Inc. | 2003-08-28 |
| K970287 | LUMBAR PUNCTURE KIT | B.Braun Medical, Inc. | 1997-04-07 |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | Smiths Industries Medical Systems, Inc. | 1996-10-18 |
| K882405 | HYPODERMIC NEEDLE SHEATH HOLDER | Ansr Ent., Inc. | 1988-06-29 |
Legacy Summary#
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FDA Review#
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