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510(k) K770920

THORACIC DRAINAGE SET, ARGYLE DUAL by Sherwood Medical Industries — Product Code GAZ

K770920 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "THORACIC DRAINAGE SET, ARGYLE DUAL". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
May 20, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K930512 — SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (July 23, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)

FDA data resources