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510(k) K955366

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS by Rand Scientific Corp. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
November 22, 1995
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 Rand Scientific Corp.

  • K963856 — RAND NASAL PACKING (October 18, 1996)
  • K961081 — SPIRIT RIDGE SILICONE CARVING BLOCK (May 22, 1996)
  • K955777 — PMMA CLASIC (May 16, 1996)
  • K961057 — DURALASTIC SHEETING II (May 16, 1996)
  • K961080 — MEDIAL MALAR IMPLANT (April 19, 1996)
  • K961071 — THE MAGNUM CHIN IMPLANT (April 19, 1996)
  • K961124 — THE NAUTILUS (April 19, 1996)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K952165 — TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS (June 30, 1995)

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