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510(k) K895817

HERMAL WOUND CARE KIT by Stiefel Research Institute, Inc. — Product Code NAD

K895817 is an FDA 510(k) premarket notification submitted by Stiefel Research Institute, Inc. for the device "HERMAL WOUND CARE KIT". The FDA issued a decision of Substantially Equivalent on January 19, 1990. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Stiefel Research Institute, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1990
Date Received
September 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
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)
  • K896724 — CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. (January 9, 1990)
  • K893996 — CUSIS ULTRASOUND SKIN IMAGING SYSTEM (September 21, 1989)

Other clearances for product code NAD

  • K254246 — LT Antibacterial Foam with Silver Dressing (September 10, 2026)
  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)

FDA data resources