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
20817325023737	K092732	000
00817325023498	K092732	000
20817325023478	K092732	000
20817325023454	K092732	000
20817325023430	K092732	000
20817325023416	K092732	000
20817325023409	K092732	000
10850034735112	K092732	000
10850034735105	K092732	000
10850034735099	K092732	000
20817325023522	K092732	000
20817325023621	K092732	000
20817325023720	K092732	000
20817325023713	K092732	000
20817325023706	K092732	000
20817325023690	K092732	000
20817325023683	K092732	000
20817325023669	K092732	000
20817325023652	K092732	000
20817325023645	K092732	000
20817325023638	K092732	000
10850034735082	K092732	000
10850034735075	K092732	000
10850034735068	K092732	000
28809083941714	K092732	000
00851255007586	K092732	000
20851255007115	K092732	000
20851255007108	K092732	000
20851255007092	K092732	000
00851255007081	K092732	000
00851255007074	K092732	000
00851255007067	K092732	000
00851255007050	K092732	000
28809083941691	K092732	000
28809083941707	K092732	000
10850034735051	K092732	000
10850034735044	K092732	000
28809083941783	K092732	000
18809083941779	K092732	000
28809083941769	K092732	000
28809083941752	K092732	000
28809083941745	K092732	000
28809083941738	K092732	000
28809083941721	K092732	000
20851255007047	K092732	000
20817325023089	K092732	000
20817325022464	K092732	000
20817325020927	K092732	000
20817325020910	K092732	000
20817325020903	K092732	000
20817325020897	K092732	000
20817325020880	K092732	000
20817325020873	K092732	000
20817325020866	K092732	000
20817325020859	K092732	000
20817325022976	K092732	000
20817325022983	K092732	000
20817325023072	K092732	000
20817325023065	K092732	000
20817325023058	K092732	000
20817325023041	K092732	000
20817325023034	K092732	000
20817325023027	K092732	000
20817325023010	K092732	000
20817325023003	K092732	000
20817325022990	K092732	000
20817325020842	K092732	000
20817325020835	K092732	000
20817325020828	K092732	000
00817120020258	K092732	000
20817120020245	K092732	000
20817120020238	K092732	000
20817325023515	K092732	000
20817325023508	K092732	000
20817325023485	K092732	000
20817325023461	K092732	000
10817325023440	K092732	000
20817325023423	K092732	000
00817120020265	K092732	000
00817120020272	K092732	000
20817325020811	K092732	000
20817325020804	K092732	000
20817325020798	K092732	000
00817325020787	K092732	000
20817325020774	K092732	000
20817325020767	K092732	000
00817325020756	K092732	000
20817325020743	K092732	000
20817325020736	K092732	000
20817325023744	K092732	000