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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 K922319
Device Name OMNI LAPAROSCOPE
Applicant
EXPANDED OPTICS, INC.
7382 BOLSA AVE.
WESTMINSTER,  CA  92683
Applicant Contact ANITA THIBEAULT
Correspondent
EXPANDED OPTICS, INC.
7382 BOLSA AVE.
WESTMINSTER,  CA  92683
Correspondent Contact ANITA THIBEAULT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/18/1992
Decision Date 04/23/1993
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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