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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 K150377
Device Name Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
Applicant
Sony Electronics, Inc.
1 Sony Dr., Mail Stop 3c5
Park Ridge,  NJ  07656
Applicant Contact Amarjit Andy Singh Jowandha
Correspondent
Sony Electronics, Inc.
1 Sony Dr., Mail Stop 3c5
Park Ridge,  NJ  07656
Correspondent Contact Amarjit Andy Singh Jowandha
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/13/2015
Decision Date 07/29/2015
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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