FDA 510(k) Application Details - K221365

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K221365
Device Name Laparoscope, General & Plastic Surgery
Applicant ARK Surgical, Ltd.
13 Wadi El Hadj
Nazareth IL
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Contact Stav Tori
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 05/12/2022
Decision Date 08/25/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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