FDA 510(k) Application Details - K241401

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K241401
Device Name Laparoscope, General & Plastic Surgery
Applicant Stryker Endoscopy
5900 Optical Ct
San Jose, CA 95138 US
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Contact Sekar Divya
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 05/17/2024
Decision Date 08/15/2024
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

FDA Source Information for K241401


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