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510(k) K011945

RIGID GAS PERMEABLE CONTACT LENS SOLUTION by Polymer Technology Corp. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2001
Date Received
June 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

Other clearances by Polymer Technology Corp.

  • K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K003932 — BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • 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)
  • K980133 — BAUSCH & LOMB WETTING AND SOAKING SOLUTION (March 11, 1998)
  • 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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