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510(k) K871706

Device
OPTHA PREP
Applicant
TREACE MEDICAL, INC.
510(k) number
K871706
Product code
HMT  
Decision
Substantially Equivalent (SESE)
Decision date
1987-05-18
Date received
1987-05-01
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#

Contact
THOMAS, JR
Address
Suite 400 22 N. Second St. Memphis TN US 38103 38103

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
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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