Triangular Bandage CAT.#191
FDA 510(k) K802006 · Pollak (Intl.), Ltd.
510(k) numberK802006
Submission
- Device name
- Triangular Bandage CAT.#191
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILI – Sling, Arm
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3640
- Specialty
- Physical Medicine
Other 510(k)s with product code ILI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912661 | Matrx, Pyramid Triangle BandageILI · Traditional | Matrix Medica, Inc. | 08/21/1991SE |
| K831549 | Arm SlingsILI · Traditional | Fred Sammons, Inc. | 06/30/1983SE |
| K831706 | Sato Family First Aid KitILI · Traditional | Food and Drug Service, Inc. | 06/24/1983SE |
| K823810 | A.C. SplintILI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823808 | Various Arm SlingILI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823664 | Universal Sling, Sling & SwatheILI · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823162 | Universal Sling, Sling & SwatheILI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K820590 | Orthopedic Soft GoodsILI · Traditional | Abco Dealers, Inc. | 03/26/1982SE |
| K812480 | Limb Holder Arm SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812478 | Maddacomfort SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
More from Maddak, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802011 | Infussion Alarm System I.A.S. CAT.#1118FLN · Traditional | 10/31/1980SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
Questions and answers
When was Triangular Bandage CAT.#191 cleared by the FDA?
Triangular Bandage CAT.#191 (K802006) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 27 days after the submission was received.
What is the product code of K802006?
The FDA product code is ILI – Sling, Arm, a Class I (low risk) device regulated under 21 CFR 890.3640.