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510(k) K873930

AEROSOL DELIVERY SYSTEM (AERO-TECH II) by Cadema Medical Products, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
September 25, 1987
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

Other clearances by Cadema Medical Products, Inc.

  • K901476 — MODIFIED ENTRAPPING FILTER (May 1, 1990)
  • K896773 — DISPOSABLE FACE MASK (January 12, 1990)
  • K896116 — ENTRAPPING FILTER (November 17, 1989)
  • K881812 — AERO-MIST NEBULIZER (July 18, 1988)
  • K800023 — LUNG AEROSOL UNIT (January 1, 1985)

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