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510(k) K943010

MAXILUBE by Mission Pharmacal Co. — Product Code KMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1995
Date Received
June 24, 1994
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

Other clearances by Mission Pharmacal Co.

  • K901223 — VACUUM ERECTION DEVICE (VED) (May 4, 1990)
  • K843382 — UROCYSTIN (January 8, 1985)

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  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)