Chemonucleolysis Table
FDA 510(k) K833509 · Stryker Corp.
510(k) numberK833509
Submission
- Device name
- Chemonucleolysis Table
- Applicant
- Stryker Corp.
Mchenry, IL, US - Received
- October 11, 1983
- Decision date
- November 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWY – Table, Operating-Room, Non-Electrical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FWY
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|---|---|---|---|
| K883457 | ASST-3000 Spinal Surgery TableFWY · Traditional | Orthopedic Systems, Inc. | 08/26/1988SE |
| K873478 | Skytron Model 130 Surgical TableFWY · Traditional | Skytron, Div. the Kmw Group, Inc. | 09/24/1987SE |
| K800118 | Chick Surgical TableFWY · Traditional | Warner-Lambert Co. | 02/05/1980SE |
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Questions and answers
When was Chemonucleolysis Table cleared by the FDA?
Chemonucleolysis Table (K833509) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 48 days after the submission was received.
What is the product code of K833509?
The FDA product code is FWY – Table, Operating-Room, Non-Electrical, a Class I (low risk) device regulated under 21 CFR 878.4950.