FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RADOVAN SUBCUTANEOUS TISSUE EXPANDER
K Number: K771224
·
Decision Oct 11, 1977
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
9
Review Days
98
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Basic Information
- Device Name
- RADOVAN SUBCUTANEOUS TISSUE EXPANDER
- K Number
- K771224
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Heyer Schulte Corp.
- Date Received
- July 5, 1977
- Decision Date
- October 11, 1977
- Product Code
- LCJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
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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 |
| 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 |