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U.S. Department of Health and Human Services

Product Classification

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Device anti fog solution and accessories, endoscopy
Definition To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Physical State anti fog solution; applicator- typically a foam pad or sponge, spray can, bottle, or cloth; container to hold solution
Technical Method Apply solution to lens, typically by spraying or wiping.
Target Area endoscopic lens
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOCT
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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