Fitting/Dialyzer
FDA 510(k) K760815 · Cobe Laboratories, Inc.
510(k) numberK760815
Submission
- Device name
- Fitting/Dialyzer
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- October 12, 1976
- Decision date
- November 19, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTG – Illuminator, Remote
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K801065 | Nikkiso Parallel Flow DialyzersFTG · Traditional | Int'L Marketing & Sales Corp. | 08/07/1980SE |
More from Int'L Marketing & Sales Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Fitting/Dialyzer cleared by the FDA?
Fitting/Dialyzer (K760815) received a 510(k) decision of Substantially Equivalent on November 19, 1976, 38 days after the submission was received.
What is the product code of K760815?
The FDA product code is FTG – Illuminator, Remote, a Class II (moderate risk) device regulated under 21 CFR 878.4580.