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510(k) K933265

ACU-DISPO-CE(TM) by Acuderm, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
July 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Acuderm, Inc.

  • K933516 — ACU-E PUNCH (March 24, 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)
  • K854877 — ACU-SYRINGE W/WO NEEDLES (February 19, 1986)
  • K832583 — SABOURAUD DEXTROSE AGAR (September 12, 1983)
  • K832582 — MYCOSEL AGAR (September 12, 1983)

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  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)