Specimen Collection Pan
FDA 510(k) K800309 · Sage Products, Inc.
510(k) numberK800309
Submission
- Device name
- Specimen Collection Pan
- Applicant
- Sage Products, Inc.
Mchenry, IL, US - Received
- February 12, 1980
- Decision date
- February 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code FMH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | Tri-Tech, Inc. | 09/17/1990SE |
| K823763 | Various-Specimen CollectorsFMH · Traditional | Cordis Corp. | 01/19/1983SE |
| K820180 | Calculi Filter CupFMH · Traditional | Omnimedical | 02/05/1982SE |
| K812933 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 11/06/1981SE |
| K802340 | Specimen SetFMH · Traditional | American Pharmaseal Div. Ahsc | 10/10/1980SE |
| K802002 | Urine Specimen Container #'S 1013-1016FMH · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K800947 | Midstream Collection KitFMH · Traditional | Sage Products, Inc. | 05/30/1980SE |
| K800233 | Abco Midstream Urine Collection SetFMH · Traditional | Abco Dealers, Inc. | 02/26/1980SE |
| K792710 | Para-Pak Clean VialFMH · Traditional | Meridian Diagnostics, Inc. | 01/28/1980SE |
| K792156 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 12/10/1979SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K972705 | Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-PlasticFMI · Traditional | 04/30/1998SE |
| K980490 | Sage Products Inc, Sharps Disposal Containers with Screw Top CapsMMK · Traditional | 02/24/1998SE |
| K973911 | 2 Gallon Alternate Care Sharps ContainerFMI · Traditional | 10/29/1997SE |
| K972279 | Sharps ShuttleFMI · Traditional | 08/29/1997SE |
| K970135 | Nitrile GlovesLZC · Traditional | 08/25/1997SE |
| K972302 | Pocket Count or SafetcountLWH · Traditional | 07/25/1997SE |
| K964168 | Procedure Specific KitsFXX · Traditional | 03/03/1997SE |
| K963986 | STP System Pva with ZincLIO · Traditional | 11/08/1996SE |
| K964026 | STP System - SafLIO · Traditional | 11/07/1996SE |
| K964027 | STP System-Pva with MercuryLIO · Traditional | 11/01/1996SE |
Questions and answers
When was Specimen Collection Pan cleared by the FDA?
Specimen Collection Pan (K800309) received a 510(k) decision of Substantially Equivalent on February 26, 1980, 14 days after the submission was received.
What is the product code of K800309?
The FDA product code is FMH – Container, Specimen, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.