FDA 510(k)

DSM 생물의료 칼슘 포스파트 케미컬 미크로스페이어스水泥

K-번호: K173572 · 2018-05-09

신청자Kensey Nash Corporation Dba Dsm Biomedical

결정일2018-05-09

제품 코드MQV

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정대체적으로 동일

기기 요약

DSM Biomedical Calcium Phosphate Cement with Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2018-05-09 under 510(k) number K173572. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DSM Biomedical Calcium Phosphate Cement with Microspheres?

DSM Biomedical Calcium Phosphate Cement with Microspheres is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K173572.

When did DSM Biomedical Calcium Phosphate Cement with Microspheres receive FDA 510(k) clearance?

DSM Biomedical Calcium Phosphate Cement with Microspheres received FDA 510(k) clearance on 2018-05-09, under 510(k) number K173572.

Who is the listed applicant for DSM Biomedical Calcium Phosphate Cement with Microspheres?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Calcium Phosphate Cement with Microspheres?

The FDA product code for DSM Biomedical Calcium Phosphate Cement with Microspheres is MQV.

Kensey Nash Corporation Dba Dsm Biomedical를 신청인으로 등재한 기타 기록

K173362DSM 생물의료 칼슘 포스파트 케미컬 케멘트 K170245DSM 생물의료 치아 뼈 이식 K160474DSM 생물의료 돼지 심장막 치료막

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