FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RADOVAN SUBCUTANEOUS TISSUE EXPANDER
K Number: K833502
·
Decision Feb 3, 1984
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
13
Review Days
121
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Basic Information
- Device Name
- RADOVAN SUBCUTANEOUS TISSUE EXPANDER
- K Number
- K833502
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- American Heyer Schulte
- Date Received
- October 5, 1983
- Decision Date
- February 3, 1984
- 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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AlloX2 Pro Tissue Expanders
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Other Clearances by American Heyer Schulte
| K Number | Device Name | ||
|---|---|---|---|
| K840172 | VENTRAL WALL DEFECT REDUCT SILO | Jun 27, 1984 | Substantially Equivalent |
| K834593 | ONE-PIECE SHUNT | Apr 3, 1984 | Substantially Equivalent |
| K833698 | AMER. V. MUELLER SURG. STAPLES ILA | Jan 25, 1984 | Substantially Equivalent |
| K833704 | AMER. V. MUELLER SURGICALSTAPLES-CARTR | Dec 29, 1983 | Substantially Equivalent |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | Sep 29, 1983 | Substantially Equivalent |
| K823790 | VENTRICULAR ACCESS SYSTEM | Apr 28, 1983 | Substantially Equivalent |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | Apr 12, 1983 | Substantially Equivalent |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | Aug 16, 1982 | Substantially Equivalent |
| K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | Feb 18, 1982 | Substantially Equivalent |
| K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | Jun 26, 1981 | Substantially Equivalent |