Atrion Medical Autogenous Tissue Collector
FDA 510(k) K971100 · Atrion Medical Products, Inc.
510(k) numberK971100
Submission
- Device name
- Atrion Medical Autogenous Tissue Collector
- Applicant
- Atrion Medical Products, Inc.
Arab, AL, US - Received
- March 26, 1997
- Decision date
- May 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Atrion Medical Autogenous Tissue Collector cleared by the FDA?
Atrion Medical Autogenous Tissue Collector (K971100) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 58 days after the submission was received.
What is the product code of K971100?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.