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510(k) K860960

RARE EARTH INTRA-OCULAR MAGNET by Ameritek, Inc. — Product Code HPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
March 13, 1986
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

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  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K983190 — DBEST OPIATES TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)

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)
  • K880855 — PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG (April 1, 1988)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)