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510(k) K931449

Device
MSP OPHTHALMIC (EYE SPUD)
Applicant
MEDICAL STERILE PRODUCTS, INC.
510(k) number
K931449
Product code
HNA  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-31
Date received
1993-03-23
Regulation
886.4350
Classification name
Spud, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID WISHINSKY
Address
P.O. Box 338 Bo. Ensenada Rd. 413, Km 0.2 Rincon PR US 00677 00677

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874963MANUAL OPHTHALMIC SURGICAL INSTRUMENTSSolway, Inc.1987-12-23

Legacy Summary#

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FDA Review#

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