FDA.reportPublic FDA data

510(k) K761253

Device
CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM
Applicant
Edward Weck, Inc.
510(k) number
K761253
Product code
HND
Decision
Substantially Equivalent (SESE)
Decision date
1976-12-16
Date received
1976-12-13
Regulation
886.4350
Classification name
Spatula, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HND#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863990THORNTON TITANIUM SILVER SPATULAKeeler Instruments, Inc.1986-10-31
K810937ANIS IRRIGATING SPATULAAmerican V. Mueller1981-05-15
K801609MADDOX LENS SPATULA CAT. #7245Edward Weck, Inc.1980-08-13
K801608MCCULLEY CONTINUOUS SUTURE TIGHTNEREdward Weck, Inc.1980-08-12
K791983SPATULA'S #'S 7618,7248,7240,7242,5108Edward Weck, Inc.1979-10-04