Lactosorb Sheets
FDA 510(k) K992158 · Biomet, Inc.
510(k) numberK992158
Submission
- Device name
- Lactosorb Sheets
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- June 25, 1999
- Decision date
- August 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Lactosorb Sheets cleared by the FDA?
Lactosorb Sheets (K992158) received a 510(k) decision of Substantially Equivalent on August 20, 1999, 56 days after the submission was received.
What is the product code of K992158?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.