FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALGISITE M
K Number: K983210
·
Decision Dec 10, 1998
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
221
Applicant Total
423
Review Days
87
Basic Information
- Device Name
- ALGISITE M
- K Number
- K983210
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITH & NEPHEW, INC.
- Date Received
- September 14, 1998
- Decision Date
- December 10, 1998
- Product Code
- KMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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