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510(k) Data Aggregation
K Number
K971515Device Name
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)
Manufacturer
Date Cleared
1997-05-20
(25 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
BIOMED DEVICES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PROMED 38 SOFBLU (Toric) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and refractive astigmatism not exceeding 10 Diopters.
The PROMED 38 SOFBLU (Spherical) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit reffactive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Device Description
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K Number
K970615Device Name
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
Manufacturer
Date Cleared
1997-03-19
(29 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
BIOMED DEVICES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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