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510(k) K854507

Device
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
Applicant
STORZ INSTRUMENT CO.
510(k) number
K854507
Product code
LXP  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-07
Date received
1985-11-12
Regulation
886.4155
Classification name
Plug, Scleral
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAN REGAN
Address
3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022186SCLERAL PLUGS, 19 AND 20 GAUGEMicrovision, Inc.2003-02-26
K990872SCLERAL PLUGS, 19 AND 20 GAUGEOphthalmic Consultants, Inc.1999-07-13
K945114VISITEC SCLERAL PLUGVisitec Co.1995-02-23
K925671DISPOSABLE SCLERAL PLUGSO.R. Specialties, Inc.1993-08-02
K880952PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, Inc.1988-05-13
K880953ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUGAdvanced Surgical Products, Inc.1988-05-13
K871604MVS 19 AND MVS 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, Inc.1987-06-12
K840693DISPOSABLE SCLERAL GLOBE PLUGInnovative Surgical Products, Inc.1984-05-22
K831193SCLERAL PLUGMedical Instrument Development Laboratories, Inc.1983-06-30

Legacy Summary#

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FDA Review#

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