ATOVEN

Powered Laser Surgical Instrument

BIO-MED U.S.A., INC.

The following data is part of a premarket notification filed by Bio-med U.s.a., Inc. with the FDA for Atoven.

Pre-market Notification Details

• Device ID: K133774
• 510k Number: K133774
• Device Name: ATOVEN
• Classification: Powered Laser Surgical Instrument
• Applicant: BIO-MED U.S.A., INC. 111 ELLISON ST. Paterson, NJ 07505
• Contact: Young Chi
• Correspondent: Young Chi; BIO-MED U.S.A., INC. 111 ELLISON ST. Paterson, NJ 07505
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-12
• Decision Date: 2014-06-06
• Summary: summary