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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 K895545
Device Name V*S*R(TM) SCOPE
Applicant
Vsr Enterprises Corp.
P.O. Box 819
Walton Beach,  FL  32549
Applicant Contact EGGERS, JR.
Correspondent
Vsr Enterprises Corp.
P.O. Box 819
Walton Beach,  FL  32549
Correspondent Contact EGGERS, JR.
Regulation Number870.1875
Classification Product Code
LDE  
Date Received09/13/1989
Decision Date 11/15/1989
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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