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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 K895446
Device Name CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
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 Received09/08/1989
Decision Date 11/27/1989
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
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