TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)

Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

HEINZ KURZ

The following data is part of a premarket notification filed by Heinz Kurz with the FDA for Titanium Vocal Fold Medializing Implant, Models 5001 001 (female), And 5001 003 (male).

Pre-market Notification Details

• Device ID: K991324
• 510k Number: K991324
• Device Name: TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
• Classification: Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
• Applicant: HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144
• Contact: Dagmar S Maser
• Correspondent: Dagmar S Maser; HEINZ KURZ TUEBINGER STRASSE 3 Dusslingen, DE D-72144
• Product Code: KHJ
• CFR Regulation Number: 874.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-19
• Decision Date: 1999-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EHKM50010031	K991324	000
EHKM50010011	K991324	000
EHKM50010001	K991324	000