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510(k) K860058

DENPAX by Nissho Iwai American Corp. — Product Code EBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1986
Date Received
January 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Suction Operatory
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances for product code EBR

  • K925367 — A-DEC 7284 CUSPIDOR, CASCADE (April 11, 1994)
  • K770600 — OROPHARYNGEAL SUCTION AIRWAY (April 8, 1977)