Abco Suction Canister
FDA 510(k) K851316 · Abco Dealers, Inc.
510(k) numberK851316
Submission
- Device name
- Abco Suction Canister
- Applicant
- Abco Dealers, Inc.
Milwaukee, WI, US - Received
- April 2, 1985
- Decision date
- May 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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| K950677 | Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional | Atrium Medical Corp. | 04/13/1995SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | Precision Medical, Inc. | 12/12/1994SE |
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| K880894 | Allergist SyringesFMF · Traditional | 03/31/1988SE |
| K872875 | Stretch Gauze BandagesNAD · Traditional | 09/04/1987SE |
| K872874 | Microscope Cover GlassesKES · Traditional | 08/10/1987SE |
| K872797 | Non-Skid Shoe CoversFXP · Traditional | 08/04/1987SE |
| K871465 | Thermometer SheathsFLL · Traditional | 05/11/1987SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | 08/01/1986SE |
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Questions and answers
When was Abco Suction Canister cleared by the FDA?
Abco Suction Canister (K851316) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 36 days after the submission was received.
What is the product code of K851316?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.