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510(k) K962182

BURLEW INFANT HOOD by Promedic, Inc. — Product Code FOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1996
Date Received
June 6, 1996
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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Other clearances for product code FOG

  • K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE (November 18, 1997)
  • 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)
  • K780220 — HOOD, INFANT OXYGEN (April 10, 1978)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)