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510(k) K872591

HARD CONTACT LENS REMOVER. ITEM #289 by Magnivision, Inc. — Product Code KYE

K872591 is an FDA 510(k) premarket notification submitted by Magnivision, Inc. for the device "HARD CONTACT LENS REMOVER. ITEM #289". The FDA issued a decision of Substantially Equivalent on August 4, 1987. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420. Magnivision, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1987
Date Received
July 1, 1987
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 Magnivision, Inc.

  • K900778 — ITEM #272 MAGNIF-EYES CONTACT LENS CASE (March 30, 1990)
  • K900777 — ITEM #273 CONTACT LENS CASES (March 30, 1990)
  • K897085 — COMFEES(R) + CON-PAK(TM) LENS CASE (February 28, 1990)
  • K897084 — CONFEES(R)+ CONTACT LENS HOLDER (February 28, 1990)
  • K882384 — DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 (June 23, 1989)
  • K890533 — ITEM #352/#CS352* CONTACT LENS CASES (June 23, 1989)
  • K872567 — SOFT CONTACT LENS REMOVER (August 10, 1987)

Other clearances for product code KYE

  • K872567 — SOFT CONTACT LENS REMOVER (August 10, 1987)
  • K871130 — CONTACT LENS TWEEZERS (May 12, 1987)
  • K870072 — SUMMIT OPTICS CONTACT LENS REMOVER (February 12, 1987)
  • K850984 — MARLIN SOFT LENS HANDLER (September 10, 1985)
  • 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)
  • K780664 — SOFT LENS REMOVER/INSERTER/MANIPULATOR (May 17, 1978)

FDA data resources