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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K780738
Device Name PENTAX ST-1A
Applicant
HAL-HEN CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HAL-HEN CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/02/1978
Decision Date 07/17/1978
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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