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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name extractor, vacuum, fetal
510(k) Number K881306
Device Name CMI VACUUM DELIVERY SYSTEM #003C AND #004C
Applicant
CHALLENGE MFG., INC.
P.O. BOX 5877
BEND,  OR  97708
Applicant Contact EMILY SMITH
Correspondent
CHALLENGE MFG., INC.
P.O. BOX 5877
BEND,  OR  97708
Correspondent Contact EMILY SMITH
Regulation Number884.4340
Classification Product Code
HDB  
Date Received03/28/1988
Decision Date 06/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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