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510(k) K780220

HOOD, INFANT OXYGEN by Shiley, Inc. — Product Code FOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
February 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hood, Oxygen, Infant
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
Submission Type

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  • K910923 — BCD ADVANCED (April 9, 1991)
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  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
  • K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (July 3, 1990)
  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

Other clearances for product code FOG

  • K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE (November 18, 1997)
  • K962182 — BURLEW INFANT HOOD (July 15, 1996)
  • K955482 — SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (January 30, 1996)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K792144 — DISPOSA-HOOD (December 5, 1979)
  • K791861 — OXYGEN HOODS (October 4, 1979)
  • K790860 — RT-HOOD (May 29, 1979)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)