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510(k) K980550

WHISTLE WATCH by Harwill Medical (Pty) , Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1998
Date Received
February 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

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  • K983204 — HARWILL MEDICAL U-KLIP UMBILICAL CLAMP (February 26, 1999)

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