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510(k) K952780

URINARY GEL DRAINAGE SYSTEM by P.A.M., Inc. — Product Code EYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1995
Date Received
June 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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