Fluoroscope Band Bag
FDA 510(k) K861785 · Medi-Plast Intl., Inc.
510(k) numberK861785
Submission
- Device name
- Fluoroscope Band Bag
- Applicant
- Medi-Plast Intl., Inc.
Atlanta, GA, US - Received
- May 8, 1986
- Decision date
- June 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Fluoroscope Band Bag cleared by the FDA?
Fluoroscope Band Bag (K861785) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 36 days after the submission was received.
What is the product code of K861785?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.