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510(k) K780267

CATH TRAY W/OUT CATHETER by Latex Ind., Inc. — Product Code EYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1978
Date Received
February 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Latex Ind., Inc.

  • K812058 — AKRON URINARY DRAINAGE BAT (July 31, 1981)
  • K810281 — UROLOGICAL CATHETERS (February 25, 1981)
  • K791674 — BLADDER RETENTION CATHETERIZATION TRAY (November 5, 1979)
  • K781751 — CATHETER, AKRON FOLEY TEFLON (January 22, 1979)
  • K781433 — AKRON MALE EXTERNAL CATHETER (November 3, 1978)
  • K772277 — BLADDER RETENTION-CATHETHERIZATIONTRAY (March 2, 1978)
  • K772340 — CATHETERIZATION KIT 732016-732018 (February 24, 1978)
  • K772342 — ROBINSON KIT - 750014 & 750016 (February 24, 1978)
  • K772341 — BLADDER KIT - 734000 (February 24, 1978)
  • K780268 — BLADDER CATH KIT W/OUT CATHETER (February 24, 1978)

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  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
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