PICSI SPERM SELECTION DEVICE— 510(k) K052457

Substantially Equivalent

Biocoat, Inc.

FDA 510(k) clearance K052457 for PICSI SPERM SELECTION DEVICE, Substantially Equivalent on 2006-04-13. Applicant: Biocoat, Inc..

Clearance details

Applicant: Biocoat, Inc.
Product code: Code MQK
Advisory panel: Obstetrics/Gynecology
Date received: 2005-09-07
Decision date: 2006-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

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