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510(k) K912032

SILON(TM) TRANSPARENT WOUND DRESSING by Bio Med Sciences, Inc. — Product Code MGP

K912032 is an FDA 510(k) premarket notification submitted by Bio Med Sciences, Inc. for the device "SILON(TM) TRANSPARENT WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 20, 1991. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Bio Med Sciences, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1991
Date Received
May 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Bio Med Sciences, Inc.

  • K023136 — OLEEVA FABRIC (October 16, 2002)
  • K002109 — OLEEVA FOAM (August 31, 2000)
  • K990042 — SILON DUAL-DRESS (March 19, 1999)
  • K982036 — SILON SCAR STRIPS (August 6, 1998)
  • K952546 — SILON SILICONE TEXTILE COMPOSITE (August 7, 1995)
  • K946362 — SILON SILICONE FOAM SHEETING (July 13, 1995)
  • K945892 — SILON(R) SILICONE THERMOPLASTIC SHEETING (March 3, 1995)
  • K932214 — SILON SILICONE GEL SHEET (January 6, 1994)
  • K923150 — SILON TRANSPARENT WOUND DRESSINGS (August 27, 1992)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)

FDA data resources