Personally(Tm), Model 241 Sizes 0-12,LEFT & Right
FDA 510(k) K864786 · Coloplast Corp.
510(k) numberK864786
Submission
- Device name
- Personally(Tm), Model 241 Sizes 0-12,LEFT & Right
- Applicant
- Coloplast Corp.
Marietta, GA, US - Received
- December 8, 1986
- Decision date
- January 8, 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
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|---|---|---|---|
| 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 |
| 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 |
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| 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 |
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Questions and answers
When was Personally(Tm), Model 241 Sizes 0-12,LEFT & Right cleared by the FDA?
Personally(Tm), Model 241 Sizes 0-12,LEFT & Right (K864786) received a 510(k) decision of Substantially Equivalent on January 8, 1987, 31 days after the submission was received.
What is the product code of K864786?
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.