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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., NW
Washington,  DC  20004 -5600
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Prism Enterprises, Inc.
555 Thirteenth St., NW
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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