FDA 510(k) Applications for Medical Device Product Code "MML"
(Weights, Eyelid, External)

FDA 510(k) Number Applicant Device Name Decision Date
K170591 Altomed Limited Altomed Malhotra Platinum Segments 06/06/2017
K000127 HEINZ KURZ GMBH MEDIZINTECHNIK KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 04/12/2000
K001123 HEINZ KURZ GMBH MEDIZINTECHNIK KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 04/21/2000
K011115 HEINZ KURZ GMBH MEDIZINTECHNIK KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 05/02/2001
K994289 IOP, INC. SUTUREGROOVE 04/17/2000
K003646 IOP, INC. SUTUREGROOVE WEIGHT SIZING SET 02/22/2001
K971245 IPAX, INC. BLINK EXTERNAL EYELID WEIGHT 06/20/1997
K971242 IPAX, INC. BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) 12/17/1997
K021750 JEDMED INSTRUMENT CO. LID CHAIN EYELID WEIGHTS 01/27/2003
K990224 LABTICIAN OPHTHALMICS, INC. LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET 04/12/1999
K983607 LABTICIAN OPHTHALMICS, INC. LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS 01/08/1999
K011740 MEDDEV CORP. CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) 07/02/2001
K150986 MEDDEV CORPORATION Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants 08/17/2015


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