FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERMA-SET INFUSION SET
K Number: K822603
·
Decision Sep 14, 1982
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- PERMA-SET INFUSION SET
- K Number
- K822603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cosmetic Sciences, Inc.
- Date Received
- August 27, 1982
- Decision Date
- September 14, 1982
- Product Code
- LDR
- 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 |
|---|---|---|---|
| LDR | Controller, Infusion, Intravascular, Electronic | FDA class 2 | General Hospital |
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