Atlas FDA

SUTUREGROOVE

FDA 510(k) clearance K994289 · decided 2000-04-17

Clearance details

K-number
K994289
Device name
SUTUREGROOVE
Applicant
Iop, Inc.
Decision
Substantially Equivalent
Date received
1999-12-21
Decision date
2000-04-17
Days to decision
118 days
Clearance type
Traditional
Product code
MML
Device class
2
Regulation number
886.5700
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Costa Mesa, CA, US
Third-party review
No
Expedited review
No

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LID CHAIN EYELID WEIGHTS (K021750)Jedmed Instrument Co.2003-01-27
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) (K011740)Meddev Corp.2001-07-02
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 (K011115)Heinz Kurz GmbH Medizintechnik2001-05-02
SUTUREGROOVE WEIGHT SIZING SET (K003646)Iop, Inc.2001-02-22
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (K001123)Heinz Kurz GmbH Medizintechnik2000-04-21
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (K000127)Heinz Kurz GmbH Medizintechnik2000-04-12
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (K990224)Labtician Ophthalmics, Inc.1999-04-12
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS (K983607)Labtician Ophthalmics, Inc.1999-01-08
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (K971242)Ipax, Inc.1997-12-17
BLINK EXTERNAL EYELID WEIGHT (K971245)Ipax, Inc.1997-06-20

Recalls involving this device

No recalls on record reference this clearance.