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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: SafeGel
Classification Name: LENSES, SOFT CONTACT, DAILY WEAR
Product Code: LPL
Device Class: 2
Regulation Number: 886.5925
Medical Specialty: Ophthalmic
Registered Establishment Name: SAFILENS S.R.L.
Registered Establishment Number: 3006405660
Premarket Submission Number: K090806
Owner/Operator: Safilens S.r.l.
Owner/Operator Number: 10031920
Establishment Operations: Repackager/Relabeler; Specification Developer
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