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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 K923201
Device Name ENDOSI SUCTION IRRIGATOR
Applicant
Armm, Inc.
17744 Sampson Ln.
Huntington Beach,  CA  92647
Applicant Contact MICHAEL E HAMLIN
Correspondent
Armm, Inc.
17744 Sampson Ln.
Huntington Beach,  CA  92647
Correspondent Contact MICHAEL E HAMLIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/30/1992
Decision Date 09/23/1993
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
Predetermined Change
Control Plan Authorized		 No
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