510(k) K880329
- Device
- FACTOR II PROSTHETIC SILICONE ELASTOMER
- Applicant
- FACTOR, II, INC.
- 510(k) number
- K880329
- Product code
- GBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-01
- Date received
- 1988-01-26
- Regulation
- 878.3800
- Classification name
- Material, External Aesthetic Restoration, Used With Adhesive
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN MCFALL
- Address
- P.O. Box 1339 Lakeside AZ US 85929 85929
FDA Registration Numbers#
- 9617078
- 2243374
- 2183650
- 2023623
- 3026400135
- 3006389770
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874279 | AHH NATURAL BREAST FORM | Pacific Prosthetics, Inc. | 1987-10-29 |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Roseburg SA | 1987-07-21 |
| K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | Coloplast Corp. | 1987-01-08 |
| K864785 | AMOENA BREAST FORMS | Coloplast Corp. | 1987-01-08 |
| K853822 | AMOENA BREAST FORMS | Coloplast Corp. | 1985-09-30 |
| K851668 | PROSTHESIS OR SURGICAL PADS | Virginia Hall, Inc. | 1985-06-04 |
| K842765 | SILIMED BREAST FORM | Sil-Med Corp. | 1984-08-17 |
| K841559 | CONFORMA | Beiersdorf, Inc. | 1984-07-17 |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | Baurs Krey Assoc., Inc. | 1984-04-25 |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Delaware Prosthetics, Inc. | 1983-12-19 |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Delaware Prosthetics, Inc. | 1983-12-09 |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Delaware Prosthetics, Inc. | 1983-12-09 |
| K831831 | TRULIFE SILICONE BREAST FORM | Medeering, Ltd. | 1983-06-30 |
| K813416 | EXTERNAL BREAST PROSTHESIS | Surgical Appliance Industries, Inc. | 1982-01-18 |
| K792372 | IPOS BREAST PROSTHESIS | Ipos KG | 1979-12-19 |
Legacy Summary#
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FDA Review#
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