HMP — Pad, Eye Class I

FDA Device Classification

FDA product code HMP covers "Pad, Eye", a Class I medical device regulated under 21 CFR 878.4440. Submissions are reviewed by the General, Plastic Surgery panel. At least 17 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HMP
Device Class
Class I
Regulation Number
878.4440
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K940333certified safety mfgEYE PADMarch 7, 1994
K921349deroyal industriesSTERILE,DISPOSABLE EYE DRESSINGMay 29, 1992
K904896ulti-med intlEYE PADDecember 5, 1990
K883822consolidated industries of greater syracuseFIRST AID KIT, EYE DRESSING NSN6545-00-853-6309November 22, 1988
K874411keeler instrumentsDONALDSON NATURAL EYEPATCH 'PATIENT PAK'January 27, 1988
K864810precision therapeuticsLIDSPLINTJanuary 20, 1987
K861456pantheon productsSHEETS LYOPHILIZED COLLAGEN HEYEDRATORJuly 25, 1986
K860979keeler instrumentsDONALDSON NATURAL EYEPATCHApril 4, 1986
K851906xanmedSURGICAL EYE PACKMay 21, 1985
K850005m.s.g. health systemsVISOPROTECT OCCULAR SHIELDMarch 20, 1985
K850099rockway enterprisesVISOPROTECT: OCCULAR SHIELDMarch 20, 1985
K843197visitecVISITEC EYE SHIELDOctober 5, 1984
K803145conpharCONPHAR EYE PROTECTORFebruary 5, 1981
K802799secolEYE PADSDecember 17, 1980
K801995pollak (intl.)EYE PADS CAT.#581-599September 9, 1980
K800404medi-specMEDSPEC OPERATIVE OPTHALMIC KITApril 24, 1980
K781539nice-pak productsISO-CARE KITNovember 3, 1978