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510(k) K983448

ML UNIVERSAL TUBING by Med-Logics, Inc. — Product Code MSR

K983448 is an FDA 510(k) premarket notification submitted by Med-Logics, Inc. for the device "ML UNIVERSAL TUBING". The FDA issued a decision of Substantially Equivalent on December 18, 1998. The device falls under product code MSR (Tubing, Replacement, Phacofragmentation Unit), a Class II device regulated under 21 CFR 886.4150. Med-Logics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1998
Date Received
September 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Replacement, Phacofragmentation Unit
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Med-Logics, Inc.

  • K033293 — MED-LOGICS, MODEL ML7090 (January 13, 2004)
  • K022982 — MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (November 15, 2002)
  • K022716 — MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (October 11, 2002)
  • K010872 — ML BLADE, MODEL ML7030 (June 22, 2001)
  • 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)
  • K981071 — ML MICROKERATOME (July 23, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)

Other clearances for product code MSR

  • K993361 — TUBING EXTENSION SET (January 4, 2000)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (June 1, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)

FDA data resources