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510(k) K903402

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L by Medi-Source, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
July 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Medi-Source, Inc.

  • K890565 — GELLHORN PESSARY 33410 VARIOUS SIZES (March 29, 1989)
  • K890566 — BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES (March 15, 1989)
  • K890567 — BITE BLOCK #59430 (February 17, 1989)

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