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510(k) K850984

MARLIN SOFT LENS HANDLER by Marlin Industries — Product Code KYE

K850984 is an FDA 510(k) premarket notification submitted by Marlin Industries for the device "MARLIN SOFT LENS HANDLER". The FDA issued a decision of Substantially Equivalent on September 10, 1985. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420. Marlin Industries has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1985
Date Received
March 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Inserter/Remover Contact Lens
Device Class
Class I
Regulation Number
886.5420
Review Panel
OP
Submission Type

Other clearances by Marlin Industries

  • K850983 — MARLIN SOFT LENS TWEEZER (September 10, 1985)
  • K851497 — MARLIN CONTACT LENS CASE (May 16, 1985)

Other clearances for product code KYE

  • K872567 — SOFT CONTACT LENS REMOVER (August 10, 1987)
  • K872591 — HARD CONTACT LENS REMOVER. ITEM #289 (August 4, 1987)
  • K871130 — CONTACT LENS TWEEZERS (May 12, 1987)
  • K870072 — SUMMIT OPTICS CONTACT LENS REMOVER (February 12, 1987)
  • K850983 — MARLIN SOFT LENS TWEEZER (September 10, 1985)
  • K830738 — LENSERT CONTACT LENS CLEANING & INSERT (June 10, 1983)
  • K830496 — DMV ANGLER (March 9, 1983)
  • K782140 — REMOVER, SOFT-SERT CONTACT LENS (February 12, 1979)
  • K780931 — SOFT LENS INSERTER (June 28, 1978)
  • K780663 — CONTACT LENS REMOVER AND INSERTER (May 17, 1978)

FDA data resources