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510(k) K953096

ESSENTIAL SHAVER SYSTEM by Smith & Nephew Richards, Inc. — Product Code EQJ

K953096 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "ESSENTIAL SHAVER SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 1995. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1995
Date Received
July 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type

Other clearances by Smith & Nephew Richards, Inc.

  • K965224 — EMPOWER ANTERIOR DIRECT SCREWS (May 8, 1997)
  • K963509 — GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (January 27, 1997)
  • K960444 — FINN ROD TO ROD CONNECTOR (January 24, 1997)
  • K964163 — TRIMAX NAIL SYSTEM (December 27, 1996)
  • K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (December 5, 1996)
  • K963486 — REVISION HIP SYSTEM (November 27, 1996)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
  • K962137 — GENESIS II CONSTRAINED SYSTEM (August 2, 1996)
  • K955767 — COFIED MODULAR SHOULDER SYSTEM (April 8, 1996)

Other clearances for product code EQJ

  • K161514 — Precision Thin Reciprocating Blade, 0.010in. (January 17, 2017)
  • K041985 — XPS CURVED BUR (August 12, 2004)
  • K974232 — ESSENTIAL SHAVER SYSTEM (January 12, 1998)
  • K960853 — ACE SYSTEM (April 3, 1996)
  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 1995)
  • K953370 — KARL STORZ ENT SHAVER (September 6, 1995)
  • K950337 — KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (August 23, 1995)
  • K952609 — REDI DRILL DRILL SYSTEM (July 31, 1995)

FDA data resources