FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDSURG EQUIPMENT COVERS
K Number: K014239
·
Decision Feb 19, 2002
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
14
Applicant Total
11
Review Days
55
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Basic Information
- Device Name
- MEDSURG EQUIPMENT COVERS
- K Number
- K014239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Medsurg Connection
- Date Received
- December 26, 2001
- Decision Date
- February 19, 2002
- Product Code
- MMP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MMP | Cover, Barrier, Protective | FDA class 2 | General, Plastic Surgery |
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Other Clearances by International Medsurg Connection
| K Number | Device Name | ||
|---|---|---|---|
| K110882 | IMC INSULIN SYRINGE | Aug 18, 2011 | Substantially Equivalent |
| K110656 | IMC BLOOD COLLECTION NEEDLE | Aug 18, 2011 | Substantially Equivalent |
| K102584 | IMC HYPODERMIC NEEDLE | Jan 14, 2011 | Substantially Equivalent |
| K102969 | IMC PISTON SYRINGES | Dec 20, 2010 | Substantially Equivalent |
| K100991 | IMC SURGICAL DRAPE | Oct 5, 2010 | Substantially Equivalent |
| 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 |
| K971159 | SURGICAL DRAPES | Jun 24, 1997 | Substantially Equivalent |