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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 K955076
Device Name SAFE TEE
Applicant
Pearson Strach Medical
1102 Mockingbird Ln.
Keller,  TX  76248
Applicant Contact DENNIS STRACH
Correspondent
Pearson Strach Medical
1102 Mockingbird Ln.
Keller,  TX  76248
Correspondent Contact DENNIS STRACH
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
FYD  
Date Received11/01/1995
Decision Date 04/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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