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510(k) K862070

INTER-SHARP by Intermedics Intraocular, Inc. — Product Code HNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1986
Date Received
May 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Lachrymal
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Intermedics Intraocular, Inc.

  • K841730 — BAILEY LENS SHOOTER (November 19, 1984)
  • K834543 — OCUCARE ULTRASOUND TIP & FREEDOM PACK (March 16, 1984)
  • K832525 — IRRIGATION/ASPIRATION PACK (October 4, 1983)

Other clearances for product code HNW

  • K841002 — LACHRYMAL PROBES-VARIOUS (May 9, 1984)
  • K812097 — KOI LACREMAL HOOK & DILATOR (August 18, 1981)