Silimed Breast Form
FDA 510(k) K842765 · Sil-Med Corp.
510(k) numberK842765
Submission
- Device name
- Silimed Breast Form
- Applicant
- Sil-Med Corp.
Mchenry, IL, US - Received
- July 16, 1984
- Decision date
- August 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBI – Material, External Aesthetic Restoration, Used With Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880329 | Factor II Prosthetic Silicone ElastomerGBI · Traditional | Factor, Ii, Inc. | 06/01/1988SE |
| K874279 | Ahh Natural Breast FormGBI · Traditional | Pacific Prosthetics, Inc. | 10/29/1987SE |
| K872714 | S.T.A.C.E.M. External Breast Prosthesis MammaryGBI · Traditional | Roseburg SA | 07/21/1987SE |
| K864786 | Personally(Tm), Model 241 Sizes 0-12,LEFT & RightGBI · Traditional | Coloplast Corp. | 01/08/1987SE |
| K864785 | Amoena Breast FormsGBI · Traditional | Coloplast Corp. | 01/08/1987SE |
| K853822 | Amoena Breast FormsGBI · Traditional | Coloplast Corp. | 09/30/1985SE |
| K851668 | Prosthesis or Surgical PadsGBI · Traditional | Virginia Hall, Inc. | 06/04/1985SE |
| K841559 | ConformaGBI · Traditional | Beiersdorf, Inc. | 07/17/1984SE |
| K841171 | Trilicon Brease Prosthesis DifferentGBI · Traditional | Baurs Krey Assoc., Inc. | 04/25/1984SE |
| K832151 | PDM Siloxane Prosthetic OrbitGBI · Traditional | Delaware Prosthetics, Inc. | 12/19/1983SE |
More from Delaware Prosthetics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972521 | Navigator (Stylet) 2006GAH · Traditional | 10/01/1997SE |
| K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IIFJS · Traditional | 07/18/1997SE |
| K961194 | Antimicrobial Mediastinal Silicone DrainGBW · Traditional | 08/08/1996SE |
| K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional | 06/26/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | 03/11/1996SE |
| K955463 | Grip-A-BootsLXZ · Traditional | 01/23/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | 01/04/1996SN |
| K926496 | Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional | 05/24/1995SE |
| K926495 | Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional | 02/02/1994SE |
| K926408 | Sil-Slip Flat Suction DrainGBX · Traditional | 02/02/1994SE |
Questions and answers
When was Silimed Breast Form cleared by the FDA?
Silimed Breast Form (K842765) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 32 days after the submission was received.
What is the product code of K842765?
The FDA product code is GBI – Material, External Aesthetic Restoration, Used With Adhesive, a Class I (low risk) device regulated under 21 CFR 878.3800.