FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
K Number: K983065
·
Decision Dec 1, 1998
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
61
Review Days
90
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Basic Information
- Device Name
- MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
- K Number
- K983065
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Corp.
- Date Received
- September 2, 1998
- Decision Date
- December 1, 1998
- Product Code
- LFL
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | Dec 3, 2001 | Substantially Equivalent |
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| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | Apr 23, 2001 | Substantially Equivalent |