Support Products Example Proset Cast
FDA 510(k) K830650 · Isopedix Corp.
510(k) numberK830650
Submission
- Device name
- Support Products Example Proset Cast
- Applicant
- Isopedix Corp.
Mchenry, IL, US - Received
- March 3, 1983
- Decision date
- July 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITG – Bandage, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3025
- Specialty
- Physical Medicine
Other 510(k)s with product code ITG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873111 | Conforma(Tm) Plaster BandagesITG · Traditional | The Kendal Co. | 10/09/1987SE |
| K862115 | Dekna Band KitITG · Traditional | Deknatel, Inc. | 08/19/1986SE |
| K842573 | T.P.G. Cast TapeITG · Traditional | The Poly Group, Inc. | 08/10/1984SE |
| K840416 | HexceliteITG · Traditional | Hexcel Medical | 03/23/1984SE |
| K833732 | Non Wetting Undercast PaddingITG · Traditional | American Medical Disposable, Inc. | 12/12/1983SE |
| K832992 | Soffban Orthopedic PaddingITG · Traditional | Smith & Nephew, Inc. | 11/14/1983SE |
| K832237 | Orthopedic Casting Tape MaxcastITG · Traditional | Cutter Laboratories, Inc. | 08/16/1983SE |
| K831492 | Yesona Plaster of Paris BandageITG · Traditional | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | 06/30/1983SE |
| K820890 | Urethane Orthopaedic Casting TapeITG · Traditional | Hexcel Medical | 06/23/1982SE |
| K820155 | Specialist Cast PaddingITG · Traditional | Stan-Pak Ent. | 02/12/1982SE |
Questions and answers
When was Support Products Example Proset Cast cleared by the FDA?
Support Products Example Proset Cast (K830650) received a 510(k) decision of Substantially Equivalent on July 7, 1983, 126 days after the submission was received.
What is the product code of K830650?
The FDA product code is ITG – Bandage, Cast, a Class I (low risk) device regulated under 21 CFR 890.3025.