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510(k) K770120

MOUTH WASH TRAY by Pharmaseal Div., Baxter Healthcare Corp. — Product Code FMA

K770120 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "MOUTH WASH TRAY". The FDA issued a decision of Substantially Equivalent on January 28, 1977. The device falls under product code FMA (Depressor, Tongue, Non-Surgical), a Class I device regulated under 21 CFR 880.6230. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1977
Date Received
January 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Depressor, Tongue, Non-Surgical
Device Class
Class I
Regulation Number
880.6230
Review Panel
HO
Submission Type

Other clearances by Pharmaseal Div., Baxter Healthcare Corp.

  • K792369 — HYPERALIMENTATION DRESSING TRAY (December 10, 1979)
  • K792141 — CONTINUOUS FLUSH DEVICE (December 5, 1979)
  • K792019 — PHADECODE XA INHIBITOR ASSAY (November 5, 1979)
  • K791773 — VENTILATOR TUBE WITH FILTER (October 22, 1979)
  • K791156 — AMIPAQUE MYELOGRAM TRAY (July 30, 1979)
  • K790896 — TWO-WAY ANESTHESIA FILTER (June 5, 1979)
  • K790409 — LOW DEAD SPACE INSULIN SYRINGE (April 24, 1979)
  • K782069 — TRAY, AUXILLARY BLOCK (January 4, 1979)
  • K781797 — PREP TRAY, PREOPERATIVE SKIN (November 8, 1978)
  • K781680 — MONITORING, PRESSURE KIT (October 6, 1978)

Other clearances for product code FMA

  • K992995 — AROMATIC AND FLAVORED TONGUE DEPRESSOR (December 9, 1999)
  • K842461 — TONGUE DEPRESSOR (November 30, 1984)
  • K830705 — MINI LANCET-BLOOD LANCET (April 8, 1983)
  • K821177 — BITE STICK (May 21, 1982)

FDA data resources