510(k) K170305
- Device
- Spinal Manometer NRFit; Spinal Manometer LUER
- Applicant
- PAJUNK GmbH Medizintechnologie
- 510(k) number
- K170305
- Product code
- FMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-25
- Date received
- 2017-01-31
- Regulation
- 880.2500
- Classification name
- Manometer, Spinal-fluid
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Christian G.H. Quass
- Address
- Karl-Hall-Str 1 Geisingen DE 78187 78187
FDA Registration Numbers#
- 3009750712
- 2521402
- 2433012
- 2011171
- 1921846
- 3013764800
- 2523676
- 1423537
- 9611612
- 1319639
- 2029015
Source Documents#
Other 510(k) Records For Product Code FMJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K910089 | MEGA LUMBAR PUNCTURE KIT | Megadyne Medical Products, Inc. | 1991-06-20 |
| K882405 | HYPODERMIC NEEDLE SHEATH HOLDER | Ansr Ent., Inc. | 1988-06-29 |
Legacy Summary#
summary
FDA Review#
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