MANAN

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.

Pre-market Notification Details

• Device ID: K974743
• 510k Number: K974743
• Device Name: MANAN
• 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