Mucous Specimen Trap
FDA 510(k) K913643 · Medical Device Inspection Co., Inc.
510(k) numberK913643
Submission
- Device name
- Mucous Specimen Trap
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- August 14, 1991
- Decision date
- October 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYZ – Trap, Sterile Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | Electromedics, Inc. | 02/05/1993SE |
| K902883 | Tissue/Polyp Trap SystemBYZ · Traditional | Triton Technology, Inc. | 09/12/1990SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | Delta Medical Industries | 04/05/1984SE |
| K834467 | Specimen TrapBYZ · Traditional | Microvasive | 02/17/1984SE |
| K822557 | Specimen AdaptorBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K822556 | Critical Measurement UnitBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K791847 | Aspri-LukeBYZ · Traditional | Medical Marketing Group | 10/02/1979SE |
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| K931594 | Thera-Turn CM-1000 Mattress Overlay SystemIOQ · Traditional | 12/21/1993SE |
| K933581 | Powermatic Treatment TableINQ · Traditional | 11/05/1993SE |
| K933580 | Power Work TableINQ · Traditional | 11/05/1993SE |
| K933578 | Powermatic Mat PlatformINQ · Traditional | 11/05/1993SE |
| K933577 | Powermatic Examination TableINQ · Traditional | 09/30/1993SE |
| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
| K912075 | C-Section TrayKNA · Traditional | 04/07/1992SESK |
| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
Questions and answers
When was Mucous Specimen Trap cleared by the FDA?
Mucous Specimen Trap (K913643) received a 510(k) decision of Substantially Equivalent on October 10, 1991, 57 days after the submission was received.
What is the product code of K913643?
The FDA product code is BYZ – Trap, Sterile Specimen, a Class II (moderate risk) device regulated under 21 CFR 880.6740.