Steiger Tunneling Instrument 285
FDA 510(k) K840529 · Evermed, Inc.
510(k) numberK840529
Submission
- Device name
- Steiger Tunneling Instrument 285
- Applicant
- Evermed, Inc.
Walker, MI, US - Received
- February 8, 1984
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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Questions and answers
When was Steiger Tunneling Instrument 285 cleared by the FDA?
Steiger Tunneling Instrument 285 (K840529) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 33 days after the submission was received.
What is the product code of K840529?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.