FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLYPOLE
K Number: K861838
·
Decision Jun 9, 1986
Classifications
1
FEI Numbers
278
Registration Numbers
278
Same Product Code
35
Applicant Total
1
Review Days
27
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Basic Information
- Device Name
- POLYPOLE
- K Number
- K861838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6990
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Poly Medical Technologies, Inc.
- Date Received
- May 13, 1986
- Decision Date
- June 9, 1986
- Product Code
- FOX
- 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 |
|---|---|---|---|
| FOX | Stand, Infusion | FDA class 1 | General Hospital |
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