S.T.A.C.E.M. External Breast Prosthesis Mammary
FDA 510(k) K872714 · Roseburg SA
510(k) numberK872714
Submission
- Device name
- S.T.A.C.E.M. External Breast Prosthesis Mammary
- Applicant
- Roseburg SA
Washington, DC, US - Received
- July 10, 1987
- Decision date
- July 21, 1987
- 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 |
| 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 |
| K842765 | Silimed Breast FormGBI · Traditional | Sil-Med Corp. | 08/17/1984SE |
| 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 |
|---|---|---|
| K931155 | Staple, Fixation Bone; Screw Fixation BoneHWC · Traditional | 09/01/1994SE |
| K890081 | Calius-Isabel Canovas SunglassesHQY · Traditional | 03/09/1989SE |
| K885275 | Assenat-Bleschet SunglassesHQY · Traditional | 01/24/1989SE |
| K882392 | Burnet Laboratoire Pharmaceutique Surgical GlovesKGO · Traditional | 08/26/1988SE |
| K872715 | Universal Instrumentation(Cd) for Spinal SurgeryJDN · Traditional | 12/07/1987SN |
| K874317 | Poirier Kid-Roller Manual WheelchairIOR · Traditional | 11/17/1987SE |
| K871689 | Spectacle Frame - LorraineHQZ · Traditional | 05/29/1987SE |
| K871688 | Spectacle Frame - DanielleHQZ · Traditional | 05/29/1987SE |
| K870654 | Efer ArthroscopeHRX · Traditional | 05/14/1987SE |
| K864436 | Stavip 3000JJN · Traditional | 03/16/1987SE |
Questions and answers
When was S.T.A.C.E.M. External Breast Prosthesis Mammary cleared by the FDA?
S.T.A.C.E.M. External Breast Prosthesis Mammary (K872714) received a 510(k) decision of Substantially Equivalent on July 21, 1987, 11 days after the submission was received.
What is the product code of K872714?
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.