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510(k) K872704

AMASTIM 2000 by Amatech International, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Amatech International, Inc.

  • K875049 — MD STRIPS BG (August 23, 1988)
  • K862806 — URINE DIAGNOSTIC REAGENT STRIPS (December 4, 1986)

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