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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cap, cervical
510(k) Number K884696
Device Name RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET
Applicant
LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES
23 WELISEWITZ RD.
RINGOES,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES
23 WELISEWITZ RD.
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number884.5250
Classification Product Code
HDR  
Date Received11/09/1988
Decision Date 01/27/1989
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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