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510(k) K831635

ACU-PUNCH by Acuderm, Inc.

K831635 is an FDA 510(k) premarket notification submitted by Acuderm, Inc. for the device "ACU-PUNCH". The FDA issued a decision of Substantially Equivalent on July 7, 1983. Acuderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
May 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K854877 — ACU-SYRINGE W/WO NEEDLES (February 19, 1986)
  • K832581 — DTM-DERMATOPHYTE TEST MEDIUM (September 12, 1983)

FDA data resources