FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMC HYPODERMIC NEEDLE
K Number: K102584
·
Decision Jan 14, 2011
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
11
Review Days
128
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Basic Information
- Device Name
- IMC HYPODERMIC NEEDLE
- K Number
- K102584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- International Medsurg Connection
- Date Received
- September 8, 2010
- Decision Date
- January 14, 2011
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by International Medsurg Connection
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|---|---|---|---|
| K110882 | IMC INSULIN SYRINGE | Aug 18, 2011 | Substantially Equivalent |
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| K102969 | IMC PISTON SYRINGES | Dec 20, 2010 | Substantially Equivalent |
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| K100846 | IMC SURGICAL FACE MASK | Aug 16, 2010 | Substantially Equivalent |
| K100208 | IMC SURGICAL DRAPE | Apr 20, 2010 | Substantially Equivalent |
| K023808 | IRRIGATION SETS | Mar 10, 2003 | Substantially Equivalent |
| K022159 | PISTON SYRINGE & HYPODERMIC NEEDLE | Nov 7, 2002 | Substantially Equivalent |
| K014239 | MEDSURG EQUIPMENT COVERS | Feb 19, 2002 | Substantially Equivalent |
| K971159 | SURGICAL DRAPES | Jun 24, 1997 | Substantially Equivalent |