FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K Number: K881616
·
Decision Sep 9, 1988
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
17
Review Days
150
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Basic Information
- Device Name
- PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
- K Number
- K881616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Progress Mankind Technology
- Date Received
- April 12, 1988
- Decision Date
- September 9, 1988
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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|---|---|---|---|
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| K845035 | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 | Jul 30, 1985 | Substantially Equivalent for Some Indications |
| K845036 | TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 | Jun 26, 1985 | Substantially Equivalent |
| K834047 | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | Feb 17, 1984 | Substantially Equivalent |
| K831329 | PMT VAXIOM STEREOTACTIC SYS #FX001 | Jun 15, 1983 | Substantially Equivalent |
| K830530 | TEMP TRACE | Apr 6, 1983 | Substantially Equivalent |
| K812744 | LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER | Dec 3, 1981 | Substantially Equivalent |
| K810627 | MODEL 1301 BIOTAC (TM) | Apr 2, 1981 | Substantially Equivalent |