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510(k) K781412

OSCILLATING KNIFE AND ACCESSORIES by Codman & Shurtleff, Inc. — Product Code HMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1978
Date Received
August 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Battery-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

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  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162563 — YOGA Microcatheter (January 5, 2017)
  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)

Other clearances for product code HMY

  • K040297 — ONEUSE- PLUS MICROKERATOME (March 31, 2004)
  • K023092 — BD K-4000 MICROKERATOME SYSTEM (October 18, 2002)
  • K022637 — BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (October 16, 2002)
  • K022560 — M2 SINGLE USE MICROKERTOME (September 27, 2002)
  • K003594 — CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (March 9, 2001)
  • K002191 — CARRIAZO BARRAQUER II MICROKERATOME (October 12, 2000)
  • K992687 — MILLENIUM MICROKERATOME, MODEL IMD-001 (September 24, 1999)
  • K984537 — KERATOME SYSTEM, MODEL K3000 (May 14, 1999)
  • K981741 — CARRIAZO BARRAQUER MICROKERATOME (July 24, 1998)
  • K974243 — KERATOME SYSTEM (January 20, 1998)