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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 K943927
Device Name END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM
Applicant
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC.
430 COMMERCE DR.
DELRAY BEACH,  FL  33445
Applicant Contact MARIAN D HARDING
Correspondent
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC.
430 COMMERCE DR.
DELRAY BEACH,  FL  33445
Correspondent Contact MARIAN D HARDING
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/12/1994
Decision Date 09/16/1994
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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