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MOE — Collagen Corneal Shield Class I

FDA Device Classification

Classification Details

Product Code
MOE
Device Class
Class I
Regulation Number
886.4750
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K944872bausch and lomb healthcare and optics worldwideBIO-COR COLLAGEN CORNEAL SHIELDJuly 26, 1995
K915861chiron ophthalmicsMEDILENS-CS CORNEAL SHIELDMarch 6, 1992
K914529oasis medicalSOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSNovember 13, 1991
K913148vitaphoreCOLLAGEN SHIELD FOR ACUTE CAREOctober 15, 1991
K905825chiron ophthalmicsCOLLAGEN SHIELD, VARIOUS MODELSJune 10, 1991
K902558vitaphoreCOLLAGEN SHIELD FOR ACUTE CAREAugust 17, 1990
K901880chiron ophthalmicsMEDILENS(TM) CORNEAL SHIELDJuly 2, 1990
K896449intermedicalIM COLLAGEN SHIELDMay 24, 1990
K884962bausch and lomb pharmaceuticalADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEAFebruary 9, 1990
K885015chiron ophthalmicsCOI 72 HR COLLAGEN SHIELDJune 23, 1989
K884961bausch and lomb pharmaceuticalADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEALFebruary 13, 1989
K884960bausch and lomb pharmaceuticalADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEALFebruary 13, 1989
K885016chiron ophthalmicsCOI 24 HR COLLAGEN SHIELDFebruary 1, 1989
K884363bausch and lomb pharmaceuticalLABELING CHANGES TO BIO-COR II COLLANGEN CORNEALNovember 29, 1988
K884364bausch and lomb pharmaceuticalLABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEALNovember 29, 1988
K882762chiron ophthalmicsCOLLAGEN SHIELDSeptember 12, 1988
K874224bausch and lombBIO-COR II COLLAGEN CORNEAL SHIELDJanuary 22, 1988
K874225bausch and lombBIO-COR EXT COLLAGEN CORNEAL SHIELDJanuary 22, 1988
K862315medical technology developmentFYODOROV COLLAGEN CORNEAL SHIELDJanuary 7, 1987