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510(k) K945430

DERMAVBLADE(TM) by Hasting'S Biomedical Corp. — Product Code MDM

K945430 is an FDA 510(k) premarket notification submitted by Hasting'S Biomedical Corp. for the device "DERMAVBLADE(TM)". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1994
Date Received
August 23, 1994
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

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  • 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)

FDA data resources