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510(k) K933619

PD-PAK by General Medical Mfg. Co. — Product Code MLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 22, 1994
Date Received: July 19, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Warmer, Peritoneal Dialysate
Device Class: Class II
Regulation Number: 876.5630
Review Panel: GU
Submission Type