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U.S. Department of Health and Human Services

Product Classification
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Device temporary tissue marker
Regulation Description Implantable clip.
Definition To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Physical State May include: implantable marker, delivery device
Technical Method Marks a tissue location by being visible using imaging techniques.
Target Area Tissue intended to be removed surgically
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePBY
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4300
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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