FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AHH NATURAL BREAST FORM
K Number: K874279
·
Decision Oct 29, 1987
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
16
Applicant Total
1
Review Days
9
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Basic Information
- Device Name
- AHH NATURAL BREAST FORM
- K Number
- K874279
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Pacific Prosthetics, Inc.
- Date Received
- October 20, 1987
- Decision Date
- October 29, 1987
- Product Code
- GBI
- 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 |
|---|---|---|---|
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
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