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510(k) K092554

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES by Sunlight Medical, Inc. — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
August 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

Other clearances by Sunlight Medical, Inc.

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  • K072600 — INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL (May 19, 2008)
  • K041435 — THE STRIPPER PGD (September 29, 2004)