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510(k) K963753

NASP TRANSPARENT DRESSING by North American Sterilization & Packaging Co. — Product Code MGP

K963753 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NASP TRANSPARENT DRESSING". The FDA issued a decision of Substantially Equivalent on November 29, 1996. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1996
Date Received
September 18, 1996
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 North American Sterilization & Packaging Co.

  • K964231 — NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) (March 10, 1997)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION (December 3, 1993)
  • K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI (December 3, 1993)
  • K925161 — NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO (July 21, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K910691 — NORTEC URETERAL STENT (August 15, 1991)
  • K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES (December 18, 1990)
  • K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES (December 18, 1990)

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