FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MELOLITE
K Number: K833954
·
Decision Mar 19, 1984
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
529
Review Days
124
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Basic Information
- Device Name
- MELOLITE
- K Number
- K833954
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Smith & Nephew, Inc.
- Date Received
- November 16, 1983
- Decision Date
- March 19, 1984
- 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
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
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PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
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