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510(k) K980133

BAUSCH & LOMB WETTING AND SOAKING SOLUTION by Polymer Technology Corp. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
January 15, 1998
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

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  • K002025 — RIGID GAS PERMEABLE CONTACT LENS (October 31, 2000)
  • K001960 — RIGID GAS PERMEABLE CONTACT LENS (August 28, 2000)
  • K000795 — RIGID GAS PERMEABLE CONTACT LENS (May 26, 2000)
  • K974466 — BOSTON ADVANCE CLEANER (February 19, 1998)
  • K973217 — BOSTON LIQUID ENZYMATIC CLEANER (November 24, 1997)
  • K970698 — BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS (May 6, 1997)
  • K951552 — BOSTON CONTACT LENS CASE (June 26, 1995)

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