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510(k) K221263

Aqua Naina Plus Sterile Saline Solution by Chemtex USA, Inc. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2022
Date Received
May 2, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Chemtex USA, Inc.

  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)

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  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)
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  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K191795 — AOCup Lens Case with AODisc (July 31, 2019)
  • K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution (April 11, 2017)
  • K161819 — NNR06 Multi-Purpose Solution (November 25, 2016)