EPY — Speculum, Ent Class I

FDA Device Classification

Classification Details

Product Code
EPY
Device Class
Class I
Regulation Number
878.1800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K950086pedia palsPEDIA PALS, INCORPORATEDFebruary 7, 1995
K925754rudolf riester gmbh and co. kgECONOMOctober 8, 1993
K853588downs surgicalFIBRELIGHT NASAL SPECULADecember 18, 1985
K834189imm enterprisesJAKOBI SURG. INSTRUMENTS #7 44/47March 6, 1984
K822373treace medicalEAR SURGERY SPECULUMSeptember 9, 1982
K822370treace medicalUNIVERSAL SPECULUM HOLDERSeptember 9, 1982
K822164kelleherEAR SPECULIAugust 11, 1982
K791123xomedEAR AND NOSE SPECULAJuly 10, 1979
K780723abco dealersOTOSCOPE SPECULAMay 9, 1978
K772370edward weckBARRAQUER OVAL SPECULUM-VARIOUS SIZESJanuary 17, 1978
K772380edward weckFARRIOR OVAL SPECULUMJanuary 17, 1978
K772385edward weckTHIN-BLADED NASAL SPECULUMJanuary 17, 1978