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510(k) K801608

Device
MCCULLEY CONTINUOUS SUTURE TIGHTNER
Applicant
EDWARD WECK, INC.
510(k) number
K801608
Product code
HND  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-12
Date received
1980-07-15
Regulation
886.4350
Classification name
Spatula, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K791983SPATULA'S #'S 7618,7248,7240,7242,5108Edward Weck, Inc.1979-10-04
K761253CYCLODIALYSIS SPAT. 15MM BLADE TITANIUMEdward Weck, Inc.1976-12-16

Legacy Summary#

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FDA Review#

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