LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Lactosorb Laryngotracheal Reconstruction Implants.

Pre-market Notification Details

• Device ID: K012409
• 510k Number: K012409
• Device Name: LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
• Classification: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
• Applicant: WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Contact: Sheryl Malmberg
• Correspondent: Sheryl Malmberg; WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Product Code: NHB
• CFR Regulation Number: 874.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-30
• Decision Date: 2001-10-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841036055387	K012409	000
00841036054854	K012409	000
00841036054861	K012409	000
00841036054885	K012409	000
00841036054892	K012409	000
00841036054908	K012409	000
00841036054922	K012409	000
00841036054939	K012409	000
00841036054946	K012409	000
00841036054960	K012409	000
00841036054977	K012409	000
00841036055172	K012409	000
00841036055189	K012409	000
00841036055257	K012409	000
00841036055264	K012409	000
00841036055363	K012409	000
00841036055370	K012409	000
00841036054847	K012409	000