Shutt Precision Probes
FDA 510(k) K840558 · Concept, Inc.
510(k) numberK840558
Submission
- Device name
- Shutt Precision Probes
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- February 8, 1984
- Decision date
- April 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXB – Probe
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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| K802951 | I.M ProbesHXB · Traditional | Hogan & Hartson | 12/17/1980SE |
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| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
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Questions and answers
When was Shutt Precision Probes cleared by the FDA?
Shutt Precision Probes (K840558) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 77 days after the submission was received.
What is the product code of K840558?
The FDA product code is HXB – Probe, a Class I (low risk) device regulated under 21 CFR 888.4540.