MANAN SOFT TISSUE BIOPSY NEEDLES

Instrument, Biopsy

MEDICAL DEVICE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan Soft Tissue Biopsy Needles.

Pre-market Notification Details

• Device ID: K980122
• 510k Number: K980122
• Device Name: MANAN SOFT TISSUE BIOPSY NEEDLES
• Classification: Instrument, Biopsy
• 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: KNW
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-14
• Decision Date: 1998-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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