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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K951119
Device Name NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
Applicant
American Hydro-Surgical Instruments, Inc.
430 Commerce Dr.
Delray Beach,  FL  33445
Applicant Contact MARTINE D SCHNEIDER
Correspondent
American Hydro-Surgical Instruments, Inc.
430 Commerce Dr.
Delray Beach,  FL  33445
Correspondent Contact MARTINE D SCHNEIDER
Regulation Number880.6740
Classification Product Code
GCX  
Date Received03/10/1995
Decision Date 06/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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