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510(k) K020586

GOOD LUBRICATIONS by Biofilm, Inc. — Product Code KMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2003
Date Received
February 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Patient
Device Class
Class I
Regulation Number
880.6375
Review Panel
HO
Submission Type

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Other clearances for product code KMJ

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  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)