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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K052457
FOIA Releasable 510(k) K052457
Device Name PICSI SPERM SELECTION DEVICE
Applicant
Biocoat, Inc.
211 Witmer Rd.
Horsham,  PA  19044
Applicant Contact JAMES B JOHNSTON
Correspondent
Biocoat, Inc.
211 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact JAMES B JOHNSTON
Regulation Number884.6160
Classification Product Code
MQK  
Subsequent Product Code
MQL  
Date Received09/07/2005
Decision Date 04/13/2006
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 Yes
Predetermined Change
Control Plan Authorized		 No
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