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510(k) K944988

CUSTOM MEDICAL SUSPENSION STRAP by Custom Medical Specialties, Inc. — Product Code JAY

K944988 is an FDA 510(k) premarket notification submitted by Custom Medical Specialties, Inc. for the device "CUSTOM MEDICAL SUSPENSION STRAP". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1995
Date Received
October 12, 1994
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

Other clearances for product code JAY

  • 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)
  • K850309 — COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (February 14, 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)

FDA data resources