MANAN GWI GUIDE WIRE INTRODUCER

Trocar

MEDICAL DEVICE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan Gwi Guide Wire Introducer.

Pre-market Notification Details

• Device ID: K974745
• 510k Number: K974745
• Device Name: MANAN GWI GUIDE WIRE INTRODUCER
• Classification: Trocar
• Applicant: MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608
• Contact: Karl Swartz
• Correspondent: Karl Swartz; MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608
• Product Code: DRC
• CFR Regulation Number: 870.1390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-19
• Decision Date: 1998-04-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20886333007428	K974745	000
20886333007411	K974745	000
20886333003338	K974745	000
20886333003321	K974745	000
20886333002881	K974745	000
20886333001631	K974745	000
20886333001624	K974745	000
20886333001617	K974745	000
20886333001600	K974745	000