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510(k) K910239

NEBU-SOL METERED DOSE DISPENSER (TM) by Dey Laboratories, Inc. — Product Code BSY

K910239 is an FDA 510(k) premarket notification submitted by Dey Laboratories, Inc. for the device "NEBU-SOL METERED DOSE DISPENSER (TM)". The FDA issued a decision of Substantially Equivalent on May 22, 1991. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Dey Laboratories, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1991
Date Received
January 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type

Other clearances by Dey Laboratories, Inc.

  • K972778 — DEY VIAL SODIUM CHLORIDE 3% (October 8, 1997)
  • K880411 — DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE (February 29, 1988)
  • K875011 — DEY-PAK PURIFIED WATER, USP, STERILE (January 22, 1988)
  • K875024 — DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP (January 22, 1988)
  • K831532 — OCULAR IRRIGATING CANNULA (July 12, 1983)

Other clearances for product code BSY

  • K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (November 25, 2003)
  • K992902 — AMBU HAND POWER SUCTION PUMP (October 25, 1999)
  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (March 11, 1997)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K960488 — NEO 2 LINE SUCTION SYSTEM (April 26, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)

FDA data resources