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FYE — Dress, Surgical Class I

FDA Device Classification

Classification Details

Product Code
FYE
Device Class
Class I
Regulation Number
878.4040
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K932731johnson and johnson medicalBARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNApril 11, 1994
K912790unicor federal dept. of justiceSURGICAL GOWNSeptember 19, 1991
K910920intermedics orthopedicsPROTEKT GLOVESMay 15, 1991
K910941depuy-raynhamLIFELINER SURGICAL GLOVEMay 9, 1991
K895667clinitechSTERILE SURGICAL GOWNOctober 13, 1989
K895235protect corp. of indianaVARIOUS DISPOSABLE SURGICAL GARMENTSSeptember 19, 1989
K894760barrier conceptsCLOTHINGUARDAugust 18, 1989