510(k) K780974

BACILLUS PUMILUS by Urol, Inc. — Product Code FRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fiber, Medical, Absorbent
Device Class
Class I
Regulation Number
880.5300
Review Panel
HO
Submission Type