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510(k) K900273

TRACH CARE MDI ADAPTER by Ballard Medical Products — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1990
Date Received
January 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (March 28, 2000)
  • K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (October 20, 1999)
  • K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (May 3, 1999)
  • K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (September 11, 1998)
  • K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN (March 11, 1998)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)

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