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510(k) K041432

ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT by Biofilm, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2004
Date Received
May 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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