BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY 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 Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes.

Pre-market Notification Details

• Device ID: K092554
• 510k Number: K092554
• Device Name: BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY 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: 2009-08-20
• Decision Date: 2010-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30816633023504	K092554	000
30816633023696	K092554	000
30816633023702	K092554	000
30816633023719	K092554	000
30816633023009	K092554	000
30816633023016	K092554	000
30816633023023	K092554	000
30816633023030	K092554	000
30816633023047	K092554	000
30816633023054	K092554	000
30816633023061	K092554	000
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30816633023085	K092554	000
30816633023092	K092554	000
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30816633023115	K092554	000
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30816633023672	K092554	000
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30816633023580	K092554	000
30816633023597	K092554	000
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10816633023210	K092554	000
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30816633023245	K092554	000
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30816633023290	K092554	000
10816633023302	K092554	000
30816633023498	K092554	000