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510(k) K853345

31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE by 31st. Centruy Medical Corp. — Product Code BWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Emergency Airway
Device Class
Class II
Regulation Number
868.5090
Review Panel
AN
Submission Type

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