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510(k) K770593

CORRUGATED TUBING #770 & 771 by Surgicot, Inc. — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1977
Date Received
March 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
Review Panel
AN
Submission Type

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  • K854902 — SURGICOT STEAM TEST PACK (May 20, 1986)
  • K840541 — NEURO SPONGE (April 23, 1984)
  • K840471 — EYE SPEAR (March 16, 1984)
  • K840470 — SURGISCRIBE MARKING PEN (March 12, 1984)
  • K830739 — PRO-GUARD (March 29, 1983)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)