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510(k) K830822

Device
EYE DRAPE
Applicant
COOPERVISION, INC.
510(k) number
K830822
Product code
HMT  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-06
Date received
1983-03-15
Regulation
878.4370
Classification name
Drape, Patient, Ophthalmic
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
Permalens House 1 Botley Rd., Hedge End Southampton GB S033HB S033HB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEVisitec Co.1995-02-14
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

Legacy Summary#

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FDA Review#

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