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U.S. Department of Health and Human Services

Product Classification
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Device post breast biopsy hemostatic breast compression device
Regulation Description Mammographic x-ray system.
Definition To achieve and maintain hemostasis of a breast biopsy wound site.
Physical State The device is typically a solid material (e.g., plastic block with characteristic geometry) that can adequately interface and compress tissue at or around a bleeding biopsy wound.
Technical Method The devices are designed to be used in conjunction with stereotactic biopsy platforms.
Target Area The device generally targets skin soft tissue.
Regulation Medical Specialty Radiology
Review Panel General & Plastic Surgery
Product CodePOY
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 892.1710
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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