MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT

Unit, Electrosurgical, And Accessories, Dental

MACAN ENGINEERING CO.

The following data is part of a premarket notification filed by Macan Engineering Co. with the FDA for Macan Model Mc-4a Dental Electrosurgical Unit.

Pre-market Notification Details

• Device ID: K052622
• 510k Number: K052622
• Device Name: MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
• Classification: Unit, Electrosurgical, And Accessories, Dental
• Applicant: MACAN ENGINEERING CO. 1564 NORTH DAMEN AVE. Chicago, IL 60622
• Contact: Mickey Albergo
• Correspondent: Mickey Albergo; MACAN ENGINEERING CO. 1564 NORTH DAMEN AVE. Chicago, IL 60622
• Product Code: EKZ
• CFR Regulation Number: 872.4920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-09-23
• Decision Date: 2005-12-09
• Summary: summary

NIH GUDID Devices

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