Greco-Harvey Surfactant Bonded Cath for Anesthesio
FDA 510(k) K851244 · Cook, Inc.
510(k) numberK851244
Submission
- Device name
- Greco-Harvey Surfactant Bonded Cath for Anesthesio
- Applicant
- Cook, Inc.
New Brunswick, NJ, US - Received
- February 26, 1985
- Decision date
- November 19, 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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| K962168 | Mucus Specimen TrapKDQ · Traditional | Sage Products, Inc. | 07/22/1996SE |
| 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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Questions and answers
When was Greco-Harvey Surfactant Bonded Cath for Anesthesio cleared by the FDA?
Greco-Harvey Surfactant Bonded Cath for Anesthesio (K851244) received a 510(k) decision of Substantially Equivalent on November 19, 1985, 266 days after the submission was received.
What is the product code of K851244?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.