Macroporepx Pediatric System
FDA 510(k) K002207 · Macropore Biosurgery, Inc.
510(k) numberK002207
Submission
- Device name
- Macroporepx Pediatric System
- Applicant
- Macropore Biosurgery, Inc.
San Diego, CA, US - Received
- July 21, 2000
- Decision date
- July 11, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Macroporepx Pediatric System cleared by the FDA?
Macroporepx Pediatric System (K002207) received a 510(k) decision of Substantially Equivalent on July 11, 2001, 355 days after the submission was received.
What is the product code of K002207?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.