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510(k) K962168

MUCUS SPECIMEN TRAP by Sage Products, Inc. — Product Code KDQ

K962168 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "MUCUS SPECIMEN TRAP". The FDA issued a decision of Substantially Equivalent on July 22, 1996. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Sage Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1996
Date Received
June 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Sage Products, Inc.

  • K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC (April 30, 1998)
  • K980490 — SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS (February 24, 1998)
  • K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER (October 29, 1997)
  • K972279 — SHARPS SHUTTLE (August 29, 1997)
  • K970135 — NITRILE GLOVES (August 25, 1997)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)
  • K964168 — PROCEDURE SPECIFIC KITS (March 3, 1997)
  • K963986 — STP SYSTEM PVA WITH ZINC (November 8, 1996)
  • K964026 — STP SYSTEM - SAF (November 7, 1996)
  • K964027 — STP SYSTEM-PVA WITH MERCURY (November 1, 1996)

Other clearances for product code KDQ

  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (October 6, 2006)
  • K043582 — OCEAN CHEST DRAIN (January 21, 2005)
  • K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (May 5, 1999)
  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (July 26, 1996)
  • K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (April 13, 1995)
  • K941818 — PM9000 VAC TRAP (December 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)
  • K912704 — ATRIUM 2000 CHEST DRAIN (August 26, 1991)

FDA data resources