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510(k) K880855

PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG by Richard James, Inc. — Product Code HPN

K880855 is an FDA 510(k) premarket notification submitted by Richard James, Inc. for the device "PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code HPN (Magnet, Permanent), a Class I device regulated under 21 CFR 886.4445. Richard James, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1988
Date Received
March 1, 1988
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 by Richard James, Inc.

  • K902835 — FTS-100 FLUID TRANSFER SYSTEM (August 10, 1990)

Other clearances for product code HPN

  • K905237 — EYE SEE INSTRUMENT (February 14, 1991)
  • K896473 — H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR (February 9, 1990)
  • K860960 — RARE EARTH INTRA-OCULAR MAGNET (March 31, 1986)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

FDA data resources