Basin Pack
FDA 510(k) K802538 · Texas Medical Products, Inc.
510(k) numberK802538
Submission
- Device name
- Basin Pack
- Applicant
- Texas Medical Products, Inc.
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- October 31, 1980
- 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 |
| 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 |
| K760085 | Basin, Sterile (#3200)FNY · Traditional | Concord Laboratories, Inc. | 07/20/1976SE |
More from Concord Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893417 | Surgifresh Sub-Micron Mask No. 901008-000FXX · Traditional | 06/22/1989SE |
| K870932 | Surgifresh Surgical Smoke Removal · Traditional | 03/31/1987SE |
| K851575 | Dr. Bruno Lnage Mini Photometer · Traditional | 10/18/1985SE |
| K830634 | Cardiotomy FilterJOD · Traditional | 06/30/1983SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | 01/12/1982SE |
| K810532 | Disposable StopcockDTZ · Traditional | 04/23/1981SE |
| K810515 | Disposable 2-STAGE CannulaDWF · Traditional | 04/23/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | 03/05/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | 01/16/1981SE |
| K802544 | Disposable Quick Release Perfusion AdapDTL · Traditional | 01/16/1981SE |
Questions and answers
When was Basin Pack cleared by the FDA?
Basin Pack (K802538) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 16 days after the submission was received.
What is the product code of K802538?
The FDA product code is FNY – Basin, Emesis, a Class I (low risk) device regulated under 21 CFR 880.6730.