DISPOSABLE LIGHT HANDLE AND ADAPTOR

Light, Surgical, Accessories

ASPEN SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Aspen Surgical Products, Inc. with the FDA for Disposable Light Handle And Adaptor.

Pre-market Notification Details

• Device ID: K020304
• 510k Number: K020304
• Device Name: DISPOSABLE LIGHT HANDLE AND ADAPTOR
• Classification: Light, Surgical, Accessories
• Applicant: ASPEN SURGICAL PRODUCTS, INC. 7425 CLYDE PARK, SUITE G Grand Rapids, MI 49315 -0404
• Contact: Roy Melling
• Correspondent: Roy Melling; ASPEN SURGICAL PRODUCTS, INC. 7425 CLYDE PARK, SUITE G Grand Rapids, MI 49315 -0404
• Product Code: FTA
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-01-29
• Decision Date: 2002-02-14

NIH GUDID Devices

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