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510(k) K854877

ACU-SYRINGE W/WO NEEDLES by Acuderm, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1986
Date Received
December 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Acuderm, Inc.

  • K933516 — ACU-E PUNCH (March 24, 1994)
  • K933265 — ACU-DISPO-CE(TM) (March 7, 1994)
  • K933137 — ACU-SUTURE KIT (February 22, 1994)
  • K930043 — ACU-EVAC (February 9, 1994)
  • K933866 — ACU-HEMOSTATIC RING (December 1, 1993)
  • K915000 — ACU-GUARD (January 27, 1992)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K874024 — ACU-MICRO-NEEDLE (November 23, 1987)
  • K832583 — SABOURAUD DEXTROSE AGAR (September 12, 1983)
  • K832582 — MYCOSEL AGAR (September 12, 1983)

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