LABTICIAN RETINAL IMPLANTS

Implant, Absorbable, (scleral Buckling Methods)

LABTICIAN PRODUCTS, INC.

The following data is part of a premarket notification filed by Labtician Products, Inc. with the FDA for Labtician Retinal Implants.

Pre-market Notification Details

• Device ID: K875014
• 510k Number: K875014
• Device Name: LABTICIAN RETINAL IMPLANTS
• Classification: Implant, Absorbable, (scleral Buckling Methods)
• Applicant: LABTICIAN PRODUCTS, INC. 7701 HOLIDAY DR. Sarasota, FL 34231 -5313
• Contact: David Sculati
• Correspondent: David Sculati; LABTICIAN PRODUCTS, INC. 7701 HOLIDAY DR. Sarasota, FL 34231 -5313
• Product Code: HQJ
• CFR Regulation Number: 886.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-12-04
• Decision Date: 1988-02-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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