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510(k) K790860

RT-HOOD by Plastics Supplies & Products — Product Code FOG

K790860 is an FDA 510(k) premarket notification submitted by Plastics Supplies & Products for the device "RT-HOOD". The FDA issued a decision of Substantially Equivalent on May 29, 1979. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1979
Date Received
May 7, 1979
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

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)
  • K780220 — HOOD, INFANT OXYGEN (April 10, 1978)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)

FDA data resources