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510(k) K992687

MILLENIUM MICROKERATOME, MODEL IMD-001 by Industrial & Medical Design, Inc. — Product Code HMY

K992687 is an FDA 510(k) premarket notification submitted by Industrial & Medical Design, Inc. for the device "MILLENIUM MICROKERATOME, MODEL IMD-001". The FDA issued a decision of Substantially Equivalent on September 24, 1999. The device falls under product code HMY (Keratome, Battery-Powered), a Class I device regulated under 21 CFR 886.4370. Industrial & Medical Design, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
August 10, 1999
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 Industrial & Medical Design, Inc.

  • K041405 — ASPIRATION PUMP, MODEL IMD-020 (September 2, 2004)
  • K033072 — LUCENTLITE, MODEL IMD 010 (April 1, 2004)

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)
  • 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