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510(k) K941005

DERMASSIST(TM) XEROFORM PETROLATUM DRESSING by Wilshire Medical Products — Product Code FRO

K941005 is an FDA 510(k) premarket notification submitted by Wilshire Medical Products for the device "DERMASSIST(TM) XEROFORM PETROLATUM DRESSING". The FDA issued a decision of SN on April 14, 1994. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Wilshire Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 14, 1994
Date Received
March 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Wilshire Medical Products

  • K946031 — DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING (February 27, 1995)
  • K946030 — DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING (February 27, 1995)
  • K944333 — HYDRODERM GEL WOUND DRESSING (November 10, 1994)
  • K941149 — DERMAASSIST HYDROCOLLOID DRESSING (May 20, 1994)
  • K941216 — HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING (May 20, 1994)
  • K940044 — DERMASSIST WET DRESSING, SALINE (March 3, 1994)
  • K936234 — DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING (March 3, 1994)
  • K936230 — DERMASSIST PETROLATUM GAUZE,USP (March 3, 1994)
  • K940076 — DERMASSIST WET DRESSING, WATER (March 3, 1994)
  • K935796 — HYDRODERM BREATHABLE TRANSPARENT DRESSING (February 2, 1994)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources