FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
K Number: K950178
·
Decision Jul 17, 1995
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
181
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Basic Information
- Device Name
- PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
- K Number
- K950178
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pharma-Plast Intl. A/S
- Date Received
- January 17, 1995
- Decision Date
- July 17, 1995
- Product Code
- LZE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LZE | Isometer | FDA class 1 | Orthopedic |
Other Clearances by Pharma-Plast Intl. A/S
| K Number | Device Name | ||
|---|---|---|---|
| K945617 | PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS | Feb 13, 1995 | Substantially Equivalent |