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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 K921695
Device Name ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
Applicant
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Applicant Contact ANN HOHENSEE
Correspondent
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Correspondent Contact ANN HOHENSEE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/08/1992
Decision Date 02/23/1995
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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