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510(k) K863560

URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA by Uresil Corp. — Product Code GBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)