FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SPARK-KIT(TM)
K Number: K864509
·
Decision Feb 18, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
96
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Basic Information
- Device Name
- SPARK-KIT(TM)
- K Number
- K864509
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Lyphomed, Inc.
- Date Received
- November 14, 1986
- Decision Date
- February 18, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- Third Party
- N
Other Clearances by Lyphomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910142 | SPARK KIT(R), MODIFICATION | May 14, 1991 | Unknown |
| K853019 | NITROGLYCERIN INFUSION SET | Nov 12, 1985 | Substantially Equivalent |
| K853086 | SECONDARY ADMINISTRATION SET | Aug 19, 1985 | Substantially Equivalent |
| K852881 | VENTED SECONDARY IV ADMINISTRATION SET | Aug 16, 1985 | Substantially Equivalent |
| K852882 | MAXIFILL TRANSFER SET | Aug 16, 1985 | Substantially Equivalent |
| K842678 | I.V. TRANSFER SPIKE | Oct 9, 1984 | Substantially Equivalent |
| K842345 | MAXIFILL TRANSFER SET | Aug 17, 1984 | Substantially Equivalent |