FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FACTOR II PROSTHETIC SILICONE ELASTOMER
K Number: K880329
·
Decision Jun 1, 1988
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
16
Applicant Total
3
Review Days
127
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FACTOR II PROSTHETIC SILICONE ELASTOMER
- K Number
- K880329
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Factor, Ii, Inc.
- Date Received
- January 26, 1988
- Decision Date
- June 1, 1988
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBI), ordered by most recent decision date.
AHH NATURAL BREAST FORM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMOENA BREAST FORMS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMOENA BREAST FORMS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROSTHESIS OR SURGICAL PADS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery