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510(k) K780664

SOFT LENS REMOVER/INSERTER/MANIPULATOR by Dmv Contact Lens Co. — Product Code KYE

K780664 is an FDA 510(k) premarket notification submitted by Dmv Contact Lens Co. for the device "SOFT LENS REMOVER/INSERTER/MANIPULATOR". The FDA issued a decision of Substantially Equivalent on May 17, 1978. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420. Dmv Contact Lens Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1978
Date Received
April 20, 1978
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 Dmv Contact Lens Co.

  • K830496 — DMV ANGLER (March 9, 1983)
  • K780663 — CONTACT LENS REMOVER AND INSERTER (May 17, 1978)

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)
  • K850984 — MARLIN SOFT LENS HANDLER (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)

FDA data resources