FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDI-SOL
K Number: K924571
·
Decision Apr 6, 1993
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
11
Applicant Total
1
Review Days
208
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Basic Information
- Device Name
- MEDI-SOL
- K Number
- K924571
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4730
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Orange-Sol, Inc.
- Date Received
- September 10, 1992
- Decision Date
- April 6, 1993
- Product Code
- KOX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KOX | Solvent, Adhesive Tape | FDA class 1 | General, Plastic Surgery |
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