FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STANDARD PECTORALIS MUSCLE IMPLANT
K Number: K790245
·
Decision Apr 4, 1979
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
28
Review Days
57
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Basic Information
- Device Name
- STANDARD PECTORALIS MUSCLE IMPLANT
- K Number
- K790245
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Medical Engineering Corp.
- Date Received
- February 6, 1979
- Decision Date
- April 4, 1979
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Sep 26, 1984 | Substantially Equivalent |