FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
10CC CONTROL SYRINGE
K Number: K873588
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
12
Review Days
49
Basic Information
- Device Name
- 10CC CONTROL SYRINGE
- K Number
- K873588
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- MEDI-PLAST INTL., INC.
- Date Received
- September 4, 1987
- Decision Date
- October 23, 1987
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by MEDI-PLAST INTL., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Feb 12, 1996 | Substantially Equivalent |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | Oct 22, 1986 | Substantially Equivalent |
| K861785 | FLUOROSCOPE BAND BAG | Jun 13, 1986 | Substantially Equivalent |
| K851489 | ARTERIAL-VENOUS COMPRESSION DRESSING | Jun 11, 1985 | Substantially Equivalent |
| K842136 | STERILE PAN SET | Jul 6, 1984 | Substantially Equivalent |
| K840021 | OPERATING ROOM TRAY SET | Mar 15, 1984 | Substantially Equivalent |
| K840022 | HEART CATHETERIZATION TRAY SET | Feb 4, 1984 | Substantially Equivalent |
| K811268 | BOTTLE-TO-BOTTLE | Jun 18, 1981 | Substantially Equivalent |
| K811234 | I.V. BOTTLE (RIDGID) | Jun 18, 1981 | Substantially Equivalent |
| K811233 | I.V. PLASTIC BAG | Jun 17, 1981 | Substantially Equivalent |