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510(k) K771651

AKRO-SIL FOLEY KIT 5CC by Latex Ind., Inc. — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1977
Date Received
August 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
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)
  • 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)
  • K772341 — BLADDER KIT - 734000 (February 24, 1978)
  • K772342 — ROBINSON KIT - 750014 & 750016 (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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  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
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