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510(k) K860058

DENPAX by Nissho Iwai American Corp. — Product Code EBR

K860058 is an FDA 510(k) premarket notification submitted by Nissho Iwai American Corp. for the device "DENPAX". The FDA issued a decision of Substantially Equivalent on March 12, 1986. The device falls under product code EBR (Unit, Suction Operatory), a Class I device regulated under 21 CFR 872.6640.

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)

FDA data resources