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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Manual
510(k) Number K912128
Device Name MAXI-SCOPE OR ULTRA-SCOPE
Applicant
Seiichi Mfg., Inc.
95 Riverside Dr.
Jamestown,  KY  42629
Applicant Contact SHIRLEY MASAOKA
Correspondent
Seiichi Mfg., Inc.
95 Riverside Dr.
Jamestown,  KY  42629
Correspondent Contact SHIRLEY MASAOKA
Regulation Number870.1875
Classification Product Code
LDE  
Date Received05/14/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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