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510(k) K895207

BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM by Johnson & Johnson International — Product Code FRO

K895207 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Johnson & Johnson International has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
August 17, 1989
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 Johnson & Johnson International

  • K965198 — ULTIMA TPS CEMENTED STEM (July 23, 1997)
  • K944937 — SYNTHETIC ABSORBABLE SUTURE (May 19, 1995)
  • K946245 — TIELLE* HYDROPOLYMER DRESSING (April 11, 1995)
  • K942383 — DERMIVIEW CLEAR TAPE (August 22, 1994)
  • K922918 — BARRIER SAF-TE HYDROGEL DRAPE (July 6, 1993)
  • K923807 — P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS (November 9, 1992)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K901456 — ORTHOSORB(R) ABSORBABLE PIN (August 15, 1990)
  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)

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