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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K000937
Device Name IVC TWO MEDIUM
Applicant
Invitrocare, Inc.
11408 Sorrento Valley Rd.
Suite 202
San Diego,  CA  92121
Applicant Contact ROBERT E LOVINS
Correspondent
Invitrocare, Inc.
11408 Sorrento Valley Rd.
Suite 202
San Diego,  CA  92121
Correspondent Contact ROBERT E LOVINS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/23/2000
Decision Date 05/25/2000
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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