FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SILIMED TISSUE EXPANDER
K Number: K981852
·
Decision Aug 5, 1998
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
9
Review Days
71
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Basic Information
- Device Name
- SILIMED TISSUE EXPANDER
- K Number
- K981852
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Silimed, LLC
- Date Received
- May 26, 1998
- Decision Date
- August 5, 1998
- 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 Silimed, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K974479 | SILIMED VAGINAL STENT | Aug 5, 1998 | Substantially Equivalent |
| K981835 | SILIMED MALAR IMPLANT | Jul 9, 1998 | Substantially Equivalent |
| K981851 | SILIMED SILICONE CARVING BLOCK | Jul 9, 1998 | Substantially Equivalent |
| K981850 | SILIMED CHIN IMPLANTS | Jul 9, 1998 | Substantially Equivalent |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | Jun 26, 1998 | Substantially Equivalent |
| K980221 | SILIMED NASAL RETAINER | Apr 2, 1998 | Substantially Equivalent |
| K974482 | SILIMED GLUTEAL IMPLANT | Feb 24, 1998 | Substantially Equivalent |
| K974480 | SILIMED CALF IMPLANT | Feb 24, 1998 | Substantially Equivalent |