Basin, Sterile (#3200)
FDA 510(k) K760085 · Concord Laboratories, Inc.
510(k) numberK760085
Submission
- Device name
- Basin, Sterile (#3200)
- Applicant
- Concord Laboratories, Inc.
Mchenry, IL, US - Received
- June 21, 1976
- Decision date
- July 20, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNY – Basin, Emesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6730
- Specialty
- General Hospital
Other 510(k)s with product code FNY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | American Hospital Supply Corp. | 04/23/1984SE |
| K802538 | Basin PackFNY · Traditional | Texas Medical Products, Inc. | 10/31/1980SE |
| K800440 | Sterile Sponge BowlsFNY · Traditional | Premium Plastics, Inc. | 04/29/1980SE |
| K792625 | Sterilization Process/Placenta BasinFNY · Traditional | Procter & Gamble Mfg. Co. | 01/16/1980SE |
| K771733 | 8 Emesis BasinFNY · Traditional | Bemis Health Care | 09/28/1977SE |
| K760495 | Basin, Rectangular WashFNY · Traditional | Landmark Plastics | 11/12/1976SE |
| K760494 | Basin, Round WashFNY · Traditional | Landmark Plastics | 11/12/1976SE |
| K760492 | Basin, Large or SmallFNY · Traditional | Landmark Plastics | 11/12/1976SE |
More from Landmark Plastics
| 510(k) | Device | Decision |
|---|---|---|
| K883840 | Dri-Vent Arterial Blood Sampling KitLKB · Traditional | 05/16/1989SESD |
| K871825 | Meconium Suction CatheterBSY · Traditional | 06/29/1987SE |
| K864535 | Tracheobronchial Suction Catheter, Cat. No. 6110BSY · Traditional | 01/06/1987SE |
| K862039 | Concord Care Tray · Traditional | 07/03/1986SESD |
| K854601 | Spring Guide Catheter Anesthesia Conduction CathBSO · Traditional | 01/10/1986SE |
| K854327 | Subcutaneous Tunneling Needles & HandlesGCB · Traditional | 11/13/1985SE |
| K851134 | Regional Anesthesia TraysCAZ · Traditional | 07/15/1985SESD |
| K842095 | Epidural TraysCAZ · Traditional | 07/03/1984SE |
| K841486 | Arterial Blood Sampling KitsCBT · Traditional | 05/23/1984SE |
| K840987 | Vaporized HeparinCBT · Traditional | 04/05/1984SE |
Questions and answers
When was Basin, Sterile (#3200) cleared by the FDA?
Basin, Sterile (#3200) (K760085) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 29 days after the submission was received.
What is the product code of K760085?
The FDA product code is FNY – Basin, Emesis, a Class I (low risk) device regulated under 21 CFR 880.6730.