Codman Lhalo Split Ring Retractor System
FDA 510(k) K913233 · Codman & Shurtleff, Inc.
510(k) numberK913233
Submission
- Device name
- Codman Lhalo Split Ring Retractor System
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- July 22, 1991
- Decision date
- July 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Codman Lhalo Split Ring Retractor System cleared by the FDA?
Codman Lhalo Split Ring Retractor System (K913233) received a 510(k) decision of Substantially Equivalent on July 31, 1991, 9 days after the submission was received.
What is the product code of K913233?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.