FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MLI SET
K Number: K952392
·
Decision Aug 7, 1995
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
77
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Basic Information
- Device Name
- MLI SET
- K Number
- K952392
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Technologies of Georgia
- Date Received
- May 22, 1995
- Decision Date
- August 7, 1995
- 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 Medical Technologies of Georgia
| K Number | Device Name | ||
|---|---|---|---|
| K973120 | READYCATH CATHETER | Feb 25, 1998 | Substantially Equivalent |
| K911129 | MMG BILE BAG | Aug 7, 1991 | Substantially Equivalent |
| K873136 | MMG CATH-N-PLACE | Sep 9, 1987 | Substantially Equivalent |
| K871949 | MMG DELEE SUCTION CATHETER W/MUCOUS TRAP | Jun 15, 1987 | Substantially Equivalent |
| K854821 | MMG EXTERNAL FEMALE CATHETERS | Apr 24, 1986 | Substantially Equivalent |
| K854660 | THE MMG ENTERAL FEEDING ADMINISTRATION SET | Jan 21, 1986 | Substantially Equivalent |
| K840839 | MMG FOLEY CATHETER | Apr 17, 1984 | Substantially Equivalent |
| K840897 | OXYGEN TUBING | Mar 16, 1984 | Substantially Equivalent |
| K821854 | U-200 BAG | Jul 22, 1982 | Substantially Equivalent |
| K821853 | U-100 BAG | Jul 22, 1982 | Substantially Equivalent |