FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K Number: K003283
·
Decision Dec 13, 2000
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
27
Review Days
55
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Basic Information
- Device Name
- SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
- K Number
- K003283
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterling Medivations, Inc.
- Date Received
- October 19, 2000
- Decision Date
- December 13, 2000
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Sterling Medivations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021530 | SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN | May 21, 2002 | Substantially Equivalent |
| K021487 | SIMPLICITY EASY ACCESS P INFUSION SET | May 17, 2002 | Substantially Equivalent |
| K021296 | SIMPLICITY QD EASY P INFUSION SET | May 14, 2002 | Substantially Equivalent |
| K021216 | SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS | May 3, 2002 | Substantially Equivalent |
| K021005 | SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE | Apr 25, 2002 | Substantially Equivalent |
| K020990 | SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN | Apr 10, 2002 | Substantially Equivalent |
| K020912 | SIMPLICITY EASY SOFT INFUSION SET | Apr 10, 2002 | Substantially Equivalent |
| K020629 | SIMPLICITY SIMPLEX SOFT INFUSION SET | Apr 1, 2002 | Substantially Equivalent |
| K014062 | SIMPLICITY EASY ACCESS INFUSION SET | Jan 17, 2002 | Substantially Equivalent |
| K014061 | SIMPLICITY STARPLUS SOFT INFUSION SET | Jan 17, 2002 | Substantially Equivalent |