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510(k) K050517

JSZ-MULTIPURPOSE SOLUTION by Szabocsik and Associates — Product Code LPN

K050517 is an FDA 510(k) premarket notification submitted by Szabocsik and Associates for the device "JSZ-MULTIPURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on April 13, 2005. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Szabocsik and Associates has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2005
Date Received
March 1, 2005
Clearance Type
Traditional
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 Szabocsik and Associates

  • K060924 — JSZ MULTIACTION GP CONTACT LENS SOLUTION (June 28, 2006)
  • K052074 — JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JS (September 1, 2005)

Other clearances for product code LPN

  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • K221263 — Aqua Naina Plus Sterile Saline Solution (October 12, 2022)
  • K202932 — ABT12 multi-purpose solution (May 28, 2021)
  • K210051 — OTE MPS 045 Multi-purpose Lens Care Solution (May 26, 2021)
  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)
  • K200747 — PuriLens Plus Preservative Free Saline (May 15, 2020)
  • K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (March 2, 2020)
  • 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)

FDA data resources