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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K003646
Device Name SUTUREGROOVE WEIGHT SIZING SET
Applicant
Iop, Inc.
3151 Airway Ave., Bldg. I-1
Costa Mesa,  CA  92626
Applicant Contact JASON MALECKA
Correspondent
Iop, Inc.
3151 Airway Ave., Bldg. I-1
Costa Mesa,  CA  92626
Correspondent Contact JASON MALECKA
Regulation Number886.5700
Classification Product Code
MML  
Date Received11/27/2000
Decision Date 02/22/2001
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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