Source Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus
FDA 510(k) K141336 · Varian Medical Systems, Inc.
510(k) numberK141336
Submission
- Device name
- Source Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- May 21, 2014
- Decision date
- August 6, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Source Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus cleared by the FDA?
Source Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus (K141336) received a 510(k) decision of Substantially Equivalent on August 6, 2014, 77 days after the submission was received.
What is the product code of K141336?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.