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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: FRED
Classification Name: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
Product Code: OCT
Device Class: 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology
Registered Establishment Name: Covidien
Registered Establishment Number: 2647580
Premarket Submission Number: K923843
Owner/Operator: Covidien llc
Owner/Operator Number: 1282497
Establishment Operations: Contract Manufacturer; Manufacturer
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