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510(k) K781433

AKRON MALE EXTERNAL CATHETER by Latex Ind., Inc. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
August 21, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
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)
  • 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)
  • K780267 — CATH TRAY W/OUT CATHETER (February 24, 1978)

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