KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

Weights, Eyelid, External

HEINZ KURZ GMBH MEDIZINTECHNIK

The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Kurz Upper Eyelid Implant- Platinum/iridium,models Regular 4007 003-007, Special 4007 002, 4007 008-010.

Pre-market Notification Details

• Device ID: K011115
• 510k Number: K011115
• Device Name: KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
• Classification: Weights, Eyelid, External
• Applicant: HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap
• Contact: Dagmar Maser
• Correspondent: Dagmar Maser; HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap
• Product Code: MML
• CFR Regulation Number: 886.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-12
• Decision Date: 2001-05-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EHKM40070101	K011115	000
EHKM40070091	K011115	000
EHKM40070081	K011115	000
EHKM40070071	K011115	000
EHKM40070061	K011115	000
EHKM40070051	K011115	000
EHKM40070041	K011115	000
EHKM40070031	K011115	000
EHKM40070021	K011115	000