ELECTRO-LUBE

Electrosurgical, Cutting & Coagulation & Accessories

MECTRA LABS, INC.

The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Electro-lube.

Pre-market Notification Details

• Device ID: K033880
• 510k Number: K033880
• Device Name: ELECTRO-LUBE
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424
• Contact: Charles E Allgood Jr.
• Correspondent: Charles E Allgood Jr.; MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-15
• Decision Date: 2004-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20817984011151	K033880	000
10817984011147	K033880	000
20817984010222	K033880	000
20817984010215	K033880	000
10849771037870	K033880	000