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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 K840008
Device Name O'NEIL OBSTETRIC CUP
Applicant
GOMEDICAL INDUSTRIES PTY LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GOMEDICAL INDUSTRIES PTY LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4340
Classification Product Code
HDB  
Date Received01/04/1984
Decision Date 04/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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