FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SURGITEK RECONSTRUC-NIPPLE PROSTHESIS
K Number: K842748
·
Decision Sep 26, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
28
Review Days
75
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Basic Information
- Device Name
- SURGITEK RECONSTRUC-NIPPLE PROSTHESIS
- K Number
- K842748
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Medical Engineering Corp.
- Date Received
- July 13, 1984
- Decision Date
- September 26, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | Nov 18, 1993 | Substantially Equivalent |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Mar 13, 1991 | Substantially Equivalent |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | Jan 14, 1991 | Substantially Equivalent |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | Jul 16, 1990 | Substantially Equivalent |
| K884746 | SURGITEK FLAT T-SPAN | Aug 10, 1989 | Substantially Equivalent |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Feb 8, 1989 | Substantially Equivalent |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Aug 11, 1988 | Substantially Equivalent |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | May 26, 1988 | Substantially Equivalent |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | May 26, 1988 | Substantially Equivalent |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Oct 20, 1983 | Substantially Equivalent |