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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K953673
Device Name ECLIPSE PROBE COVER
Applicant
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/07/1995
Decision Date 03/14/1996
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
Recalls CDRH Recalls
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