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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 K935146
Device Name DISPOSABLE STETHOSCOPE HEAD COVER
Applicant
Modern Medical Devices, Inc.
42307 Osgood Rd. Suite N
Fremont,  CA  94539
Applicant Contact LESLIE E MANZANILLA
Correspondent
Modern Medical Devices, Inc.
42307 Osgood Rd. Suite N
Fremont,  CA  94539
Correspondent Contact LESLIE E MANZANILLA
Regulation Number868.1930
Classification Product Code
BZS  
Date Received10/28/1993
Decision Date 07/11/1994
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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