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510(k) K200556

AquaFlate Pre-Filled Sterile Water Syringe 10mL by H R Pharmaceuticals, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2020
Date Received
March 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by H R Pharmaceuticals, Inc.

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