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510(k) K031660

FERRIS POLYMEM STERILE BREAST PAD by Ferris Mfg. Corp. — Product Code NTX

K031660 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "FERRIS POLYMEM STERILE BREAST PAD". The FDA issued a decision of Substantially Equivalent on February 22, 2005. The device falls under product code NTX (Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)), a Class I device regulated under 21 CFR 880.5630. Ferris Mfg. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2005
Date Received
May 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
Device Class
Class I
Regulation Number
880.5630
Review Panel
HO
Submission Type

A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.

Other clearances by Ferris Mfg. Corp.

  • K031307 — FERRIS POLYMEM SILVER WOUND DRESSING (October 22, 2003)
  • K002129 — FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN (August 25, 2000)
  • K991729 — FERRIS POLYOSTOMY STERILE WOUND DRESSING (August 27, 1999)
  • K990906 — FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER (April 29, 1999)
  • K984539 — FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING (March 1, 1999)
  • K982306 — POLYTUBE (September 22, 1998)
  • K932913 — FERRIS POLYMEM HYDROPHILIC WOUND DRESSING (June 7, 1994)
  • K900127 — FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) (May 18, 1990)
  • K880330 — FERRIS HYDROPHILIC DRESSING (March 23, 1988)
  • K874478 — DYNAFILM (January 14, 1988)

FDA data resources