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510(k) K945738

Device
VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
Applicant
VISITEC CO.
510(k) number
K945738
Product code
HMT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-14
Date received
1994-11-23
Regulation
878.4370
Classification name
Drape, Patient, Ophthalmic
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID A CLAPP
Address
7575 Commerce Ct. Sarasota FL US 34243 34243

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HMT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.1991-02-06
K872620SOLOS EYESITE DRAPESSolos Ophthalmology1987-07-31
K871706OPTHA PREPTreace Medical, Inc.1987-05-18
K854613SURGICAL DRAPES, OPHTHALMINCharles Atkins & Co.1986-02-13
K831340DRAIN-R-DRAPE(EYESur-Tech, Inc.1983-06-08
K830822EYE DRAPECooperVision, Inc.1983-04-06

Legacy Summary#

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FDA Review#

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