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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetrical, Ac-Powered (And Accessories)
510(k) Number K950889
Device Name ADEL 5000
Applicant
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001 -6197
Applicant Contact CHAD A COBERLY
Correspondent
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001 -6197
Correspondent Contact CHAD A COBERLY
Regulation Number884.4900
Classification Product Code
HDD  
Date Received02/28/1995
Decision Date 10/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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