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510(k) K900047

THAYER SUCTION EVACUATION CONDENSATE COLLECTION by Thayer Medical Corp. — Product Code BYH

K900047 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "THAYER SUCTION EVACUATION CONDENSATE COLLECTION". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Thayer Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1990
Date Received
January 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drain, Tee (Water Trap)
Device Class
Class I
Regulation Number
868.5995
Review Panel
AN
Submission Type

Other clearances by Thayer Medical Corp.

  • K102658 — MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTION (December 10, 2010)
  • K993101 — LITEAIRE (October 26, 2000)
  • K992722 — PRIMEAIRE (November 10, 1999)
  • K972237 — HAND HELD MEDISPACER (July 31, 1997)
  • K955805 — DUAL SPRAY MINISPACER (March 21, 1996)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)
  • K924535 — THAYER HAND HELD M.K.I. HOLDING CHAMBER (March 10, 1993)
  • K914283 — THAYER EXPANSION CHAMBER METERED DOSE INHALER (February 26, 1992)
  • K904917 — THAYER MIP ADAPTER (January 28, 1991)
  • K901739 — THAYER METERED DOSE INHALER DISPENSER/ADAPTER (October 9, 1990)

Other clearances for product code BYH

  • K946057 — AQUALARM MOISTURE SENSOR MODEL P85000 (May 5, 1995)
  • K932722 — CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (August 6, 1993)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)
  • K897057 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 16, 1990)
  • K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 9, 1990)
  • K900591 — VENT-TRAP CAT# WR1000 (March 9, 1990)
  • K885088 — THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (January 12, 1989)
  • K882739 — INTERTECH LARGE VOLUME WATER TRAP (LVW) (August 9, 1988)
  • K881790 — SAFETY DRAIN (June 21, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)

FDA data resources