Thermal Pulp Tester
FDA 510(k) K940260 · Union Broach, Div. Moyco Industries, Inc.
510(k) numberK940260
Submission
- Device name
- Thermal Pulp Tester
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
Philadelphia, PA, US - Received
- January 21, 1994
- Decision date
- March 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Thermal Pulp Tester cleared by the FDA?
Thermal Pulp Tester (K940260) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 45 days after the submission was received.
What is the product code of K940260?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.