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510(k) K840237

MAX-I-PROBE PERIODONTAL ENDODONTIC PROB by Smith & Nephew, Mpl Division — Product Code EIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
January 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Periodontic, Endodontic, Irrigating
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE (August 12, 1983)
  • K831765 — HERAPIN LOCK FLUSH SOLUTION USE KIT (July 12, 1983)
  • K830524 — HENKE JECT PRESSURE SYRINGE (March 24, 1983)
  • K830242 — MICRO 2 HYPODERMIC NEEDLES (February 15, 1983)
  • K761206 — INTEROSSEOUS NEEDLE (December 13, 1976)

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  • K851944 — MAX-I-PROBE HANDPIECE (July 1, 1985)
  • K811889 — R & S SERIES FITTING TOOLS (July 24, 1981)
  • K811594 — WATER PISTOL (July 15, 1981)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K792578 — EPIC CANNULA (January 4, 1980)
  • K792577 — ENDOVAGE SYRINGE (January 4, 1980)