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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stethoscope Head
510(k) Number K930118
Device Name STETSKINS
Applicant
Nova Diversified Concepts
3950 Maize Rd.
Columbus,  OH  43224
Applicant Contact JEFFREY J SCARPITTI
Correspondent
Nova Diversified Concepts
3950 Maize Rd.
Columbus,  OH  43224
Correspondent Contact JEFFREY J SCARPITTI
Regulation Number868.1930
Classification Product Code
BZS  
Date Received01/11/1993
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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