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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp
510(k) Number K851654
Device Name OMNIMED CLAMP
Applicant
Omni Intl., Inc.
870 Research Dr.
Unit 5
Palm Springs,  CA  92263
Applicant Contact RAMAN KADEVARI
Correspondent
Omni Intl., Inc.
870 Research Dr.
Unit 5
Palm Springs,  CA  92263
Correspondent Contact RAMAN KADEVARI
Regulation Number878.4800
Classification Product Code
HXD  
Date Received04/22/1985
Decision Date 05/31/1985
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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