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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name falloposcope
510(k) Number K974028
Device Name STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
Applicant
CONCEPTUS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Applicant Contact CONNIE ACUFF
Correspondent
CONCEPTUS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Correspondent Contact CONNIE ACUFF
Regulation Number884.1690
Classification Product Code
MKO  
Date Received10/23/1997
Decision Date 01/21/1998
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
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