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510(k) K893996

CUSIS ULTRASOUND SKIN IMAGING SYSTEM by Stiefel Research Institute, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1989
Date Received
June 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Stiefel Research Institute, Inc.

  • K914591 — L.C.S. 2000 SYSTEM (January 14, 1992)
  • K910216 — STEADFAST DENTURE ADHESIVE POWDER (March 29, 1991)
  • 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)

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