INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES

Microtools, Assisted Reproduction (pipettes)

SUNLIGHT MEDICAL, INC.

The following data is part of a premarket notification filed by Sunlight Medical, Inc. with the FDA for Intracytoplasmic Sperm And Spermatid Injection, Holding, Zone Drilling, Partial Zone Dissection And Denuding Pipettes.

Pre-market Notification Details

• Device ID: K072600
• 510k Number: K072600
• Device Name: INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
• Classification: Microtools, Assisted Reproduction (pipettes)
• Applicant: SUNLIGHT MEDICAL, INC. 12443 SAN JOSE BLVD. SUITE 602 Jacksonville, FL 32223
• Contact: Dunsong Yang
• Correspondent: Dunsong Yang; SUNLIGHT MEDICAL, INC. 12443 SAN JOSE BLVD. SUITE 602 Jacksonville, FL 32223
• Product Code: MQH
• CFR Regulation Number: 884.6130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-14
• Decision Date: 2008-05-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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