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510(k) K980100

Device
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
Applicant
STORZ INSTRUMENT CO.
510(k) number
K980100
Product code
MSR  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-01
Date received
1998-01-12
Regulation
886.4150
Classification name
Tubing, Replacement, Phacofragmentation Unit
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PATRICK G BALSMANN
Address
3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993361TUBING EXTENSION SETHurricane Medical2000-01-04
K983448ML UNIVERSAL TUBINGMed-Logics, Inc.1998-12-18
K980849SURGIN KITSurgin Surgical Instrumentation, Inc.1998-07-09
K972522ML-DISPOSABLE PAKMed-Logics, Inc.1997-09-30

Legacy Summary#

summary

FDA Review#

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