Cordis Suction Reservoir - Model Number: 910-500
FDA 510(k) K963839 · Cordis Corp.
510(k) numberK963839
Submission
- Device name
- Cordis Suction Reservoir - Model Number: 910-500
- Applicant
- Cordis Corp.
Miami Lakes, FL, US - Received
- September 24, 1996
- Decision date
- December 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4680
- Specialty
- General, Plastic Surgery
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| K930615 | Autovac Closed Wound Suction SystemGCY · Traditional | Boehringer Laboratories | 02/22/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
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Questions and answers
When was Cordis Suction Reservoir - Model Number: 910-500 cleared by the FDA?
Cordis Suction Reservoir - Model Number: 910-500 (K963839) received a 510(k) decision of Substantially Equivalent on December 12, 1996, 79 days after the submission was received.
What is the product code of K963839?
The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.