HENKE SASS WOLF OF AMERICA ARTHROSCOPE

Arthroscope

HENKE SASS WOLF OF AMERICA, INC.

The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Henke Sass Wolf Of America Arthroscope.

Pre-market Notification Details

• Device ID: K080560
• 510k Number: K080560
• Device Name: HENKE SASS WOLF OF AMERICA ARTHROSCOPE
• Classification: Arthroscope
• Applicant: HENKE SASS WOLF OF AMERICA, INC. 106 EAST 5TH AVENUE Mount Dora, FL 32757
• Contact: Lynette Howard
• Correspondent: Lynette Howard; HENKE SASS WOLF OF AMERICA, INC. 106 EAST 5TH AVENUE Mount Dora, FL 32757
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-28
• Decision Date: 2008-03-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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