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510(k) K964078

3050 SPORT-NEB by Medical Industries America, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
October 11, 1996
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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  • K940630 — 503 MAXI COMPRESSOR (February 21, 1995)
  • K905593 — SLEEPAP (April 23, 1991)

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