Codman Disposable Perforator, Model(S) 26-1222, 26-1223
FDA 510(k) K071931 · Codman & Shurtleff, Inc.
510(k) numberK071931
Submission
- Device name
- Codman Disposable Perforator, Model(S) 26-1222, 26-1223
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- July 13, 2007
- Decision date
- October 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Codman Disposable Perforator, Model(S) 26-1222, 26-1223 cleared by the FDA?
Codman Disposable Perforator, Model(S) 26-1222, 26-1223 (K071931) received a 510(k) decision of Substantially Equivalent on October 22, 2007, 101 days after the submission was received.
What is the product code of K071931?
The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.