ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET

Microtools, Assisted Reproduction (pipettes)

RESEARCH INSTRUMENTS LTD.

The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Icsi Injection Micropipette (spiked & Non-spiked), Icsi Holding Miceopipette, Assisted Hatching/zona Drilling Micropipet.

Pre-market Notification Details

• Device ID: K991261
• 510k Number: K991261
• Device Name: ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
• Classification: Microtools, Assisted Reproduction (pipettes)
• Applicant: RESEARCH INSTRUMENTS LTD. KERNICK RD. Penryn, Corwall, GB Tr 10 9dq
• Contact: David C Lansdowne
• Correspondent: David C Lansdowne; RESEARCH INSTRUMENTS LTD. KERNICK RD. Penryn, Corwall, GB Tr 10 9dq
• Product Code: MQH
• CFR Regulation Number: 884.6130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-13
• Decision Date: 1999-08-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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