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510(k) K874478

DYNAFILM by Ferris Mfg. Corp. — Product Code NAD

K874478 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "DYNAFILM". The FDA issued a decision of SN on January 14, 1988. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Ferris Mfg. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 14, 1988
Date Received
November 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Ferris Mfg. Corp.

  • K031660 — FERRIS POLYMEM STERILE BREAST PAD (February 22, 2005)
  • 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)

Other clearances for product code NAD

  • K254246 — LT Antibacterial Foam with Silver Dressing (September 10, 2026)
  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)

FDA data resources