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510(k) K830496

DMV ANGLER by Dmv Contact Lens Co. — Product Code KYE

K830496 is an FDA 510(k) premarket notification submitted by Dmv Contact Lens Co. for the device "DMV ANGLER". The FDA issued a decision of Substantially Equivalent on March 9, 1983. 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
March 9, 1983
Date Received
February 16, 1983
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.

  • K780664 — SOFT LENS REMOVER/INSERTER/MANIPULATOR (May 17, 1978)
  • 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)
  • 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)
  • 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