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510(k) K972397

EZ SPRAY by Intertex Research, Inc. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1997
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

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  • K894555 — PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (January 24, 1990)