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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K925869
Device Name SHEATHES, STERILE SHEATHES
Applicant
Mayer Laboratories
231 Fallon St.
Oakland,  CA  94607
Applicant Contact DAVID P MAYER
Correspondent
Mayer Laboratories
231 Fallon St.
Oakland,  CA  94607
Correspondent Contact DAVID P MAYER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/19/1992
Decision Date 01/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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