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510(k) K896473

H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR by Emory University School of Medicine — Product Code HPN

K896473 is an FDA 510(k) premarket notification submitted by Emory University School of Medicine for the device "H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code HPN (Magnet, Permanent), a Class I device regulated under 21 CFR 886.4445.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1990
Date Received
November 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnet, Permanent
Device Class
Class I
Regulation Number
886.4445
Review Panel
OP
Submission Type

Other clearances for product code HPN

  • K905237 — EYE SEE INSTRUMENT (February 14, 1991)
  • K880855 — PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG (April 1, 1988)
  • K860960 — RARE EARTH INTRA-OCULAR MAGNET (March 31, 1986)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

FDA data resources