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510(k) K921464

CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT by Trinity Laboratories, Inc. — Product Code GBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1992
Date Received
March 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K953929 — MID-STREAM COLLECTION SET-STERILE (November 16, 1995)
  • K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (September 21, 1995)
  • K953070 — WOUNDFOAM 4 X 4 (September 8, 1995)

Other clearances for product code GBQ

  • K941356 — MICROFLOW IRRIGATION SYSTEM (May 19, 1994)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)