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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 K980212
Device Name MITYVAC
Applicant
Prism Technologies, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact HOWARD M HOLSTEIN, ESQ.
Correspondent
Prism Technologies, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN, ESQ.
Regulation Number884.4340
Classification Product Code
HDB  
Date Received01/21/1998
Decision Date 07/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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