FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
MULTICURE(R) S GEL PAD
K Number: K950085
·
Decision Jul 13, 1995
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
1
Review Days
184
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Basic Information
- Device Name
- MULTICURE(R) S GEL PAD
- K Number
- K950085
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Multigestion (Deutschland) GmbH
- Date Received
- January 10, 1995
- Decision Date
- July 13, 1995
- Product Code
- KIC
- 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 |
|---|---|---|---|
| KIC | Cushion, Flotation | FDA class 1 | Physical Medicine |
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