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510(k) K792069

TRACHEOSTOMY CARE KIT by National Patent Development Corp. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1979
Date Received
October 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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  • K820028 — ZEON COMPOSITE RESIN LIGHT CURE SYS (March 11, 1982)
  • K820006 — ZEON COMPOSITE RESIN SYSTEM (January 22, 1982)
  • K811446 — HYDRON WOUND DRESSING KIT (June 12, 1981)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K792136 — HYPO-ALLERGENIC PLASTIC TAPE (January 16, 1980)

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