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510(k) K072600

INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES by Sunlight Medical, Inc. — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2008
Date Received
September 14, 2007
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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  • K152581 — LifeGlobal Micro Tips (April 11, 2016)
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  • K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette (December 18, 2015)
  • K133257 — BIOPSY PIPETTES (May 16, 2014)
  • K102480 — INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZO (April 19, 2011)
  • K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (April 30, 2010)
  • K041435 — THE STRIPPER PGD (September 29, 2004)