FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMOENA AFFINITY MODEL #802
K Number: K915382
·
Decision Jan 14, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
12
Applicant Total
54
Review Days
46
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Basic Information
- Device Name
- AMOENA AFFINITY MODEL #802
- K Number
- K915382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coloplast Corp.
- Date Received
- November 29, 1991
- Decision Date
- January 14, 1992
- Product Code
- KCZ
- 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 |
|---|---|---|---|
| KCZ | Prosthesis, Breast, External, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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COSMET
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CALSSIQUE OR MYSTIQUE
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CLASSIQUE
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ALMOST U, INC. BREAST PROSTHESIS
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·General, Plastic Surgery
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