FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCALP VEIN SET
K Number: K870995
·
Decision Jul 31, 1987
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
14
Review Days
142
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Basic Information
- Device Name
- SCALP VEIN SET
- K Number
- K870995
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mac Lee Medical Products
- Date Received
- March 11, 1987
- Decision Date
- July 31, 1987
- 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 Mac Lee Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K872953 | DISPOSABLE I.V. ADMINISTRATION SET | Jan 6, 1988 | Substantially Equivalent |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Nov 17, 1987 | Substantially Equivalent |
| K864778 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864779 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864777 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864781 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864782 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K864783 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K864780 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K841710 | MAC LEE VAGINAL IRRIGATOR | Jun 19, 1984 | Substantially Equivalent |