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510(k) K760816

PNEUMOTACHOGRAPHY SYSTEM by Aftercal, Inc. — Product Code GWB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 29, 1976
Date Received: October 12, 1976
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
Device Class: Class I
Regulation Number: 866.3740
Review Panel: MI
Submission Type