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510(k) K855132

SHAVE PREP TRAY by Dynarex Corp. — Product Code MDM

K855132 is an FDA 510(k) premarket notification submitted by Dynarex Corp. for the device "SHAVE PREP TRAY". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Dynarex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 23, 1985
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 Dynarex Corp.

  • K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (December 22, 2005)
  • K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (November 9, 2005)
  • K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (October 17, 2002)
  • K012957 — TOWEL DRAPE, MODELS 4409, 4410 (March 6, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K991694 — DYNAREX DRAIN SPONGE (July 15, 1999)
  • K991695 — DYNAREX NON-WOVEN SPONGE (July 15, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K960388 — DYNAREX NON-WOVEN SPONGE (April 1, 1996)
  • K951660 — DYNAREX GAUZE SPONGE (May 9, 1995)

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (August 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • 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)

FDA data resources