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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K820175
Device Name O.N.A.T.
Applicant
Latex Medical Devices, Inc.
502 N. Rogers St.
Bloomington,  IN  47401
Applicant Contact SIMEON VINOCUR
Correspondent
Latex Medical Devices, Inc.
502 N. Rogers St.
Bloomington,  IN  47401
Correspondent Contact SIMEON VINOCUR
Regulation Number884.4900
Classification Product Code
KNC  
Date Received01/21/1982
Decision Date 01/29/1982
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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