FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISCRENE SELF-SUPPORTING BREAST FORM
K Number: K904086
·
Decision Oct 2, 1990
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
12
Applicant Total
71
Review Days
27
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Basic Information
- Device Name
- DISCRENE SELF-SUPPORTING BREAST FORM
- K Number
- K904086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Coloplast A/S
- Date Received
- September 5, 1990
- Decision Date
- October 2, 1990
- 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 |
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CLASSIQUE
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