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510(k) K946186

CHAL-2500 by Hogan & Hartson — Product Code IPF

Clearance Details

Decision
SN ()
Decision Date
August 14, 1995
Date Received
December 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)
  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K941566 — COMPUSPEAK (June 30, 1995)
  • K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM (May 15, 1995)

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