FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTION PORT II --- FOR INTERMITTENT INJECTION
K Number: K896291
·
Decision Dec 1, 1989
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
10
Review Days
31
Basic Information
- Device Name
- INJECTION PORT II --- FOR INTERMITTENT INJECTION
- K Number
- K896291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- THE MEDI-DOSE GROUP
- Date Received
- October 31, 1989
- Decision Date
- December 1, 1989
- 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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|---|---|---|---|
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| K900651 | TS-1800 MEDICATION TRANSFER SPIKE | May 7, 1990 | Substantially Equivalent |
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| K895291 | IV DISPESNSING SPIKE | Dec 27, 1989 | Substantially Equivalent |
| K895419 | DISPOSABLE DISC FILTER | Nov 24, 1989 | Substantially Equivalent |
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| K892430 | DISPOSABLE DISC FILTER | Jul 14, 1989 | Substantially Equivalent |
| K892428 | COMBI-CAP | Jul 14, 1989 | Substantially Equivalent |