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510(k) K003594

CARRIAZO BARRAQUER SINGLE USE MICROKERATOME by Moria, Inc. — Product Code HMY

K003594 is an FDA 510(k) premarket notification submitted by Moria, Inc. for the device "CARRIAZO BARRAQUER SINGLE USE MICROKERATOME". The FDA issued a decision of Substantially Equivalent on March 9, 2001. The device falls under product code HMY (Keratome, Battery-Powered), a Class I device regulated under 21 CFR 886.4370. Moria, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2001
Date Received
November 21, 2000
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

Other clearances by Moria, Inc.

  • K172994 — EPI K Console (October 26, 2017)
  • K043183 — EPI-K (March 25, 2005)
  • K032836 — M3 MICROKERATOME (June 18, 2004)
  • K040297 — ONEUSE- PLUS MICROKERATOME (March 31, 2004)
  • K022560 — M2 SINGLE USE MICROKERTOME (September 27, 2002)
  • K002191 — CARRIAZO BARRAQUER II MICROKERATOME (October 12, 2000)
  • K981742 — ONE UP DISPOSABLE KERATOME HEAD (August 25, 1998)
  • K981741 — CARRIAZO BARRAQUER MICROKERATOME (July 24, 1998)

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)
  • 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)
  • K902857 — VISI-DRAPE OPHTHALMIC DRAPES (July 31, 1990)

FDA data resources