Anspach EG1 High Speed System, G1 Attachments
FDA 510(k) K133604 · The Anspach Effort, Inc.
510(k) numberK133604
Submission
- Device name
- Anspach EG1 High Speed System, G1 Attachments
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- November 25, 2013
- Decision date
- January 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Anspach EG1 High Speed System, G1 Attachments cleared by the FDA?
Anspach EG1 High Speed System, G1 Attachments (K133604) received a 510(k) decision of Substantially Equivalent on January 10, 2014, 46 days after the submission was received.
What is the product code of K133604?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.