FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
STERILE PLASTIC DRESSING
K Number: K944588
·
Decision Nov 7, 1994
Classifications
1
FEI Numbers
934
Registration Numbers
934
Same Product Code
183
Applicant Total
423
Review Days
49
Basic Information
- Device Name
- STERILE PLASTIC DRESSING
- K Number
- K944588
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SMITH & NEPHEW, INC.
- Date Received
- September 19, 1994
- Decision Date
- November 7, 1994
- Product Code
- KGX
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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TARGETT PATCH
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PARALLEL
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