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510(k) K850309

COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK by Ackrad Laboratories — Product Code JAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1985
Date Received
January 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Breathing Tube
Device Class
Class I
Regulation Number
868.5280
Review Panel
AN
Submission Type

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Other clearances for product code JAY

  • K944988 — CUSTOM MEDICAL SUSPENSION STRAP (January 27, 1995)
  • K873491 — BLOCK, BITE, INTUBATION (October 20, 1987)
  • K860583 — DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 (February 21, 1986)
  • K850924 — JEE FRAME (VENTILATOR CIRCUIT SUPPORT) (July 19, 1985)
  • K840844 — ENDO-SECURE (March 16, 1984)
  • K834265 — TRACH MATE (January 4, 1984)
  • K834089 — COMFIT (December 29, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833332 — SCHULTZ ENDHOLD (October 31, 1983)