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510(k) K970161

HEDGES CORNEAL WETTING PAK by Hedges Cwp, Inc. — Product Code KYG

K970161 is an FDA 510(k) premarket notification submitted by Hedges Cwp, Inc. for the device "HEDGES CORNEAL WETTING PAK". The FDA issued a decision of Substantially Equivalent on March 25, 1997. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1997
Date Received
January 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K940392 — PEREGRINE PIC MINIPULATOR (August 23, 1994)

FDA data resources