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U.S. Department of Health and Human Services

Product Classification
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Device apparatus, pneumoperitoneum, automatic
Regulation Description Endoscope and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeFDP
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
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 Not Third Party Eligible
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