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510(k) K810281

UROLOGICAL CATHETERS by Latex Ind., Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1981
Date Received
February 2, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Latex Ind., Inc.

  • K812058 — AKRON URINARY DRAINAGE BAT (July 31, 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)
  • K780267 — CATH TRAY W/OUT CATHETER (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)
  • K772340 — CATHETERIZATION KIT 732016-732018 (February 24, 1978)

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