Home / Device Classification / HNC

HNC — Specula, Ophthalmic Class I

FDA Device Classification

Classification Details

Product Code
HNC
Device Class
Class I
Regulation Number
886.4350
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022836stephens instrumentsSTEPHENS DISPOSABLE SPECULUMNovember 1, 2002
K981235laser center devOCULOSTATJuly 15, 1998
K964289eyefixEYE FIXATION SPECULUMDecember 17, 1996
K863989keeler instrumentsTHORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)October 31, 1986
K863664myocureOPHTHALMIC SURGICAL SPECULUMSeptember 25, 1986
K843196visitecVISITEC EYE SPECULUMOctober 5, 1984
K830430douglas c. mckee andEYELID SPECULUMJune 10, 1983
K801969howmedicaASNIS GUIDED SCREW SYSTEMSAugust 27, 1980
K760847v. mueller o.v. baxter healthcareFELDSTEIN BLEPHAROPLASTY CLIP SHARP PNovember 2, 1976
K760848v. mueller o.v. baxter healthcareFELDSTEIN BLEPHAROPLASTY CLIP RECTANGUNovember 2, 1976
K760849v. mueller o.v. baxter healthcareFELDSTEIN BLEPHAROSTOMY CLIP SQUARENovember 2, 1976