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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K905766
Device Name DRAINAGE TUBE RESTRAINT/WOUND COVER
Applicant
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Applicant Contact MAURICE IMONTI
Correspondent
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Correspondent Contact MAURICE IMONTI
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/27/1990
Decision Date 03/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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