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510(k) K910216

STEADFAST DENTURE ADHESIVE POWDER by Stiefel Research Institute, Inc. — Product Code KOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
January 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Denture, Acacia And Karaya With Sodium Borate
Device Class
Class I
Regulation Number
872.3400
Review Panel
DE
Submission Type

Other clearances by Stiefel Research Institute, Inc.

  • K914591 — L.C.S. 2000 SYSTEM (January 14, 1992)
  • K895818 — STEADFAST DENTURE ADHESIVE CREAM (April 3, 1990)
  • K895817 — HERMAL WOUND CARE KIT (January 19, 1990)
  • K896724 — CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. (January 9, 1990)
  • K893996 — CUSIS ULTRASOUND SKIN IMAGING SYSTEM (September 21, 1989)