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510(k) K813314

NLD IMPLANT SET by Design Research Assoc., Inc. — Product Code HMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1982
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Design Research Assoc., Inc.

  • K813315 — CALIPER-OPTHALMIC (March 1, 1982)
  • K813313 — BIOMICROSCOPY CONTACT LENS (March 1, 1982)

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  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)