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510(k) K925080

TEK-LUBE by Clinical Technology Corp. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1994
Date Received
October 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Clinical Technology Corp.

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  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K854231 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES (May 2, 1986)
  • K853507 — STERI-GRIP (September 5, 1985)
  • K852986 — GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (August 19, 1985)
  • K844565 — BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) (February 21, 1985)
  • K841272 — SICKLE-STAT HEMOGLOBIN S SCREEN KIT (April 13, 1984)
  • K823077 — URINARY BLADDER TEMP. SENSOR #81-003 (March 9, 1983)

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