FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
HAWKINS MINI-E.B.A.
K Number: K862031
·
Decision Jul 14, 1986
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
2
Review Days
47
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Basic Information
- Device Name
- HAWKINS MINI-E.B.A.
- K Number
- K862031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Pb Sales C/O Geller & Bozeman
- Date Received
- May 28, 1986
- Decision Date
- July 14, 1986
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Pb Sales C/O Geller & Bozeman
| K Number | Device Name | ||
|---|---|---|---|
| K820761 | PALM BEACH SEATING SYSTEM | Apr 21, 1982 | Substantially Equivalent |