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510(k) K823767

ERG-JET ELECTRODE by Life-Tech Intl., Inc. — Product Code HLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1983
Date Received
December 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Measuring, Lens Radius, Ophthalmic
Device Class
Class I
Regulation Number
886.1430
Review Panel
OP
Submission Type

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Other clearances for product code HLF

  • K930437 — MARCO STANDARD RADIUSGAUGES (August 9, 1993)
  • K862517 — BAUSCH & LOMB CONTACT LENS VIEWER (August 11, 1986)