FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGITEK FOERSTER MAMMARY BANDAGE
K Number: K800249
·
Decision Feb 19, 1980
Classifications
1
FEI Numbers
391
Registration Numbers
392
Same Product Code
18
Applicant Total
28
Review Days
13
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Basic Information
- Device Name
- SURGITEK FOERSTER MAMMARY BANDAGE
- K Number
- K800249
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5300
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Engineering Corp.
- Date Received
- February 6, 1980
- Decision Date
- February 19, 1980
- Product Code
- FRL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | FDA class 1 | General Hospital |
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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 |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Sep 26, 1984 | Substantially Equivalent |