FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALVE, STANDARD MODEL PUDENZE FLUSHING
K Number: K760501
·
Decision Aug 30, 1976
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
9
Review Days
7
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Basic Information
- Device Name
- VALVE, STANDARD MODEL PUDENZE FLUSHING
- K Number
- K760501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Heyer Schulte Corp.
- Date Received
- August 23, 1976
- Decision Date
- August 30, 1976
- 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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Other Clearances by Heyer Schulte Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K792096 | 2 FR KELMAN CHAMBER MAINTAINER | Nov 16, 1979 | Substantially Equivalent |
| K790842 | SUBCUTANEOUS TISSUE EXPANDER | Aug 3, 1979 | Substantially Equivalent |
| K780706 | LUMBAR NERVE ROOT SHIELD | Sep 7, 1978 | Substantially Equivalent |
| K780417 | ASEPTIC TRANSFER SET | Apr 18, 1978 | Substantially Equivalent |
| K771224 | RADOVAN SUBCUTANEOUS TISSUE EXPANDER | Oct 11, 1977 | Substantially Equivalent |
| K760778 | T-TUBE DRAIN, ROUND | Nov 3, 1976 | Substantially Equivalent |
| K760785 | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH | Nov 1, 1976 | Substantially Equivalent |
| K760784 | MISHLER 2 CHAMB FLUSHING VALVE,STAND | Nov 1, 1976 | Substantially Equivalent |