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510(k) Data Aggregation
K Number
K002932Device Name
PHACOGARD
Manufacturer
SYNTEC, INC.
Date Cleared
2001-01-04
(106 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
SYNTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K980480Device Name
SYNTEC VITMAN
Manufacturer
SYNTEC, INC.
Date Cleared
1998-05-04
(90 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
SYNTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures:
Removal of vitreous in cases of:
Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies; Opacity Inflammation Endophthalmitis Bacterial Fungal Uveitis
Removal of lens remnants after cataract surgery;
· Remove vitreous traction under the retina producing localized or complete retinal detachment;
Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;
Treatment of vitreous loss during cataract surgery;
Clean vitreous strands from the cataract wound;
Perform emulsification of cataractous lens and its removal by aspiration and irrigation;
Provide internal illumination for vitreous surgery;
Provide air pressure for maintaining intraocular pressure for retinal surgery.
Device Description
Not Found
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K Number
K971338Device Name
SYNTEC, INC. DISPOSABLE BARE END FIBER
Manufacturer
SYNTEC, INC.
Date Cleared
1997-05-06
(26 days)
Product Code
MPA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SYNTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Syntec, Inc. Disposable Bare End Fiber is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery.
Device Description
The Bare End Fiber is comprised of five basic components: the handpiece tube, the fiberoptic cable, the fiber optic cable sheath and the connector.
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