FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
K Number: K170449
·
Decision Mar 31, 2017
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
5
Review Days
44
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Basic Information
- Device Name
- Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
- K Number
- K170449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Millennium Medical Technologies, Inc.
- Date Received
- February 15, 2017
- Decision Date
- March 31, 2017
- Product Code
- MUU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MUU | System, Suction, Lipoplasty | FDA class 2 | General, Plastic Surgery |
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