FDA 510(k)
Substantially Equivalent
🇺🇸 United States
LUMBAR NERVE ROOT SHIELD
K Number: K780706
·
Decision Sep 7, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
135
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Basic Information
- Device Name
- LUMBAR NERVE ROOT SHIELD
- K Number
- K780706
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Heyer Schulte Corp.
- Date Received
- April 25, 1978
- Decision Date
- September 7, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
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|---|---|---|---|
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| 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 |
| K760501 | VALVE, STANDARD MODEL PUDENZE FLUSHING | Aug 30, 1976 | Substantially Equivalent |