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510(k) K780062

CATHETER/HEMOSTATIC/GERIATRIC by Kendall Research Center — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1978
Date Received
January 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Kendall Research Center

  • K802225 — TENDER-SORB DRAIN SPONGES (September 26, 1980)
  • K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVES (September 20, 1978)
  • K780408 — MICRONET LIGHT DRESSING SPONGE (March 22, 1978)
  • K780120 — ANESTHESIA TRAY, CAUDAL (February 6, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K772134 — SYRINGE, IRRIGATION, PRE-FILLED (November 28, 1977)
  • K771655 — CURITY PEAKOMETER (October 14, 1977)
  • K771079 — CURITY IRRIGATION TRAY (September 15, 1977)
  • K771563 — CONFORM ELASTIC NETTING (September 12, 1977)
  • K771452 — CONFORM STRETCH BANDAGE (5SIZES) (September 12, 1977)

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