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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K241502
Device Name P-SCOPE
Applicant
Oui Medical, Inc.
3000 Pegasus Park Dr. Suite 1330
Dallas,  TX  75247
Applicant Contact Adarsh M. Patil
Correspondent
Oui Medical, Inc.
3000 Pegasus Park Dr. Suite 1330
Dallas,  TX  75247
Correspondent Contact Pavan Kumar Palamkota
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GCQ  
Date Received05/28/2024
Decision Date 07/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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