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510(k) K972727

CBALK-1000 BLADE by Howard Instruments, Inc. — Product Code HNO

K972727 is an FDA 510(k) premarket notification submitted by Howard Instruments, Inc. for the device "CBALK-1000 BLADE". The FDA issued a decision of Substantially Equivalent on October 10, 1997. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Howard Instruments, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1997
Date Received
July 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Howard Instruments, Inc.

  • K063104 — FOX MEDICAL DIODE LASER SYSTEM 810NM (May 16, 2007)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K980985 — SCMD-1000 (May 1, 1998)
  • K974598 — MICROKERATOME OR THE MATE (April 22, 1998)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (April 13, 2018)
  • K172994 — EPI K Console (October 26, 2017)
  • K072102 — EPIVISION SL SYSTEM (January 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)

FDA data resources