Soft Tissue Anchoring Set Kit
FDA 510(k) K874439 · Concept, Inc.
510(k) numberK874439
Submission
- Device name
- Soft Tissue Anchoring Set Kit
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- October 28, 1987
- Decision date
- November 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRO – General Surgery Tray
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
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| K971061 | Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional | Opportunity, Inc. | 06/11/1997SN |
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| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | Associated Medical Products Co. | 03/19/1997SE |
| K970286 | Presbyterian Linen Services Surgical PacksLRO · Traditional | Medline Industries, Inc. | 03/10/1997SE |
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| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
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Questions and answers
When was Soft Tissue Anchoring Set Kit cleared by the FDA?
Soft Tissue Anchoring Set Kit (K874439) received a 510(k) decision of Substantially Equivalent on November 20, 1987, 23 days after the submission was received.
What is the product code of K874439?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.