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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 K931705
Device Name ENDOSCOPIC INSTRUMENT HOLDER
Applicant
MAYAGUEZ MEDICAL CENTER
18 CRESTWOOD DR.
TROPHY CLUB,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
MAYAGUEZ MEDICAL CENTER
18 CRESTWOOD DR.
TROPHY CLUB,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/06/1993
Decision Date 07/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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