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510(k) K830738

LENSERT CONTACT LENS CLEANING & INSERT by Jermyn Specialties of California — Product Code KYE

K830738 is an FDA 510(k) premarket notification submitted by Jermyn Specialties of California for the device "LENSERT CONTACT LENS CLEANING & INSERT". The FDA issued a decision of Substantially Equivalent on June 10, 1983. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420. Jermyn Specialties of California has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1983
Date Received
March 8, 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 Jermyn Specialties of California

  • K830737 — JERMYN OCCLUDERS KIT (June 2, 1983)

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)
  • 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