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510(k) K830781

ENDO-GUARD by Jayco Pharmaceuticals — Product Code FOG

K830781 is an FDA 510(k) premarket notification submitted by Jayco Pharmaceuticals for the device "ENDO-GUARD". The FDA issued a decision of Substantially Equivalent on March 31, 1983. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700. Jayco Pharmaceuticals has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1983
Date Received
March 11, 1983
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 by Jayco Pharmaceuticals

  • K844691 — ENDOSCOPIC ASPIRATION CATHETER SET (January 2, 1985)
  • K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR (January 2, 1985)
  • K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (January 2, 1985)
  • K842009 — ABDOMINAL PARACENTESIS TRAY (October 23, 1984)
  • K842001 — LIVER BIOPSY TRAY (October 15, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K810875 — FECAL STAINING KIT (May 1, 1981)

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)
  • 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)

FDA data resources