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510(k) K921289

INMAN MEDICAL PETROLATUM DRESSING by Inman Medical Corp. — Product Code FRO

K921289 is an FDA 510(k) premarket notification submitted by Inman Medical Corp. for the device "INMAN MEDICAL PETROLATUM DRESSING". The FDA issued a decision of Substantially Equivalent on November 10, 1992. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Inman Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1992
Date Received
March 11, 1992
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 Inman Medical Corp.

  • K933171 — INMAN IRRIGATION TAPERED PROBE (April 29, 1994)
  • K933169 — INMAN ENDOSCOPIC BLUNT DISSECTOR (April 19, 1994)
  • K933094 — INSUFFLATOR TUBING KIT W/FILTER (April 18, 1994)
  • K933382 — IMC CABLE/WIRE COVER (January 27, 1994)
  • K933774 — IMC SALINE WET DRESSING (November 8, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (September 16, 1993)
  • K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 31, 1993)
  • K933371 — IMC ENDOSCOPIC INSTRUMENT HOLDER (August 6, 1993)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • 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)

FDA data resources