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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Orbital, Extra-Ocular
510(k) Number K950599
Device Name STORS SCLERAL SPONGE II (LINCOFF DESIGN)
Applicant
Storz Ophthalmics, Inc.
21 Park Pl. Blvd. N.
Clearwater,  FL  34619
Applicant Contact NANCY S COULSON
Correspondent
Storz Ophthalmics, Inc.
21 Park Pl. Blvd. N.
Clearwater,  FL  34619
Correspondent Contact NANCY S COULSON
Regulation Number886.3340
Classification Product Code
HQX  
Date Received02/09/1995
Decision Date 03/02/1995
Decision Substantially Equivalent (SESE)
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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