PROPENCIL ESU PENCIL

Electrosurgical, Cutting & Coagulation & Accessories

BIO PROTECH, INC.

The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Propencil Esu Pencil.

Pre-market Notification Details

• Device ID: K092732
• 510k Number: K092732
• Device Name: PROPENCIL ESU PENCIL
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: BIO PROTECH, INC. TAEJANG-2 DONG Wonju-si Gangwon-do, KR
• Contact: Kevin Han
• Correspondent: Ned Devine; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-09-04
• Decision Date: 2009-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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