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510(k) K852039

Device
FLEX-LOOP FLEXIBLE EAR CORETTE
Applicant
Bionix Corp.
510(k) number
K852039
Product code
JYG
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-11
Date received
1985-05-09
Regulation
874.4420
Classification name
Curette, Ear
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES J HUTTNER
Address
2140 Old Planke Rd. Holland OH US 43528 43528

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JYG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932609EAR CURETTEEar Tech, Inc.1993-07-21
K841354CURETTETreace Medical, Inc.1984-07-06
K841001EAR CURETTE, VARIOUSPremier Dental Products Co.1984-05-29
K823916WAX CURETTE TIPTreace Medical, Inc.1983-01-21
K822273ENT CURRETTESKelleher Corp.1982-08-30
K822006OPERATIVE EAR CURRETTES & RELATED ITEMKelleher Corp.1982-08-12