Sundt Slim-Line Aneurysm Clip Applier
FDA 510(k) K982379 · Johnson & Johnson Professionals, Inc.
510(k) numberK982379
Submission
- Device name
- Sundt Slim-Line Aneurysm Clip Applier
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- July 8, 1998
- Decision date
- December 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sundt Slim-Line Aneurysm Clip Applier cleared by the FDA?
Sundt Slim-Line Aneurysm Clip Applier (K982379) received a 510(k) decision of Substantially Equivalent on December 18, 1998, 163 days after the submission was received.
What is the product code of K982379?
The FDA product code is HCI – Applier, Aneurysm Clip, a Class II (moderate risk) device regulated under 21 CFR 882.4175.