ML EYE SPEAR, MODEL ML 27 ES

Sponge, Ophthalmic

MED-LOGICS, INC.

The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Ml Eye Spear, Model Ml 27 Es.

Pre-market Notification Details

• Device ID: K002279
• 510k Number: K002279
• Device Name: ML EYE SPEAR, MODEL ML 27 ES
• Classification: Sponge, Ophthalmic
• Applicant: MED-LOGICS, INC. 30001 GOLDEN LANTERN #334 Laguna Niguel, CA 92677
• Contact: Gary Mocnik
• Correspondent: Gary Mocnik; MED-LOGICS, INC. 30001 GOLDEN LANTERN #334 Laguna Niguel, CA 92677
• Product Code: HOZ
• CFR Regulation Number: 886.4790 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-26
• Decision Date: 2000-08-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40850724001504	K002279	000