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510(k) K010872

ML BLADE, MODEL ML7030 by Med-Logics, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
March 23, 2001
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 Med-Logics, Inc.

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  • K022716 — MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (October 11, 2002)
  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K002515 — MEDLOGICS ML 4000, MODEL 4000 (February 22, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K983448 — ML UNIVERSAL TUBING (December 18, 1998)
  • K981071 — ML MICROKERATOME (July 23, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)

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