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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 K011532
Device Name MITYVAC
Applicant
PRISM ENTERPRISES, INC.
555 THIRTEENTH ST. N.W.
WASHINGTON,  DC  20004 -5600
Applicant Contact HOWARD M HOLSTEIN
Correspondent
PRISM ENTERPRISES, INC.
555 THIRTEENTH ST. N.W.
WASHINGTON,  DC  20004 -5600
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number884.4340
Classification Product Code
HDB  
Date Received05/18/2001
Decision Date 07/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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