MICROVISION SCLERAL BUCKLING COMPONENTS

Implant, Orbital, Extra-ocular

MICROVISION, INC.

The following data is part of a premarket notification filed by Microvision, Inc. with the FDA for Microvision Scleral Buckling Components.

Pre-market Notification Details

• Device ID: K023481
• 510k Number: K023481
• Device Name: MICROVISION SCLERAL BUCKLING COMPONENTS
• Classification: Implant, Orbital, Extra-ocular
• Applicant: MICROVISION, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Contact: Sheila Hemeon-heyer, Jd, Rac
• Correspondent: Sheila Hemeon-heyer, Jd, Rac; MICROVISION, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Product Code: HQX
• CFR Regulation Number: 886.3340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-17
• Decision Date: 2003-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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