FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K Number: K983385
·
Decision Mar 15, 1999
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
1
Review Days
171
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Basic Information
- Device Name
- HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
- K Number
- K983385
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hutchison Intl., Inc.
- Date Received
- September 25, 1998
- Decision Date
- March 15, 1999
- 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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