VERSABLADE

Knife, Ophthalmic

ALPHAMEDIX, INC.

The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Versablade.

Pre-market Notification Details

• Device ID: K852633
• 510k Number: K852633
• Device Name: VERSABLADE
• Classification: Knife, Ophthalmic
• Applicant: ALPHAMEDIX, INC. 10907 NORTHRIDGE SQUARE Cupertino, CA 95014
• Contact: Carl R Jordan
• Correspondent: Carl R Jordan; ALPHAMEDIX, INC. 10907 NORTHRIDGE SQUARE Cupertino, CA 95014
• Product Code: HNN
• CFR Regulation Number: 886.4350 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-06-20
• Decision Date: 1985-11-04