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510(k) K792136

HYPO-ALLERGENIC PLASTIC TAPE by National Patent Development Corp. — Product Code FPX

K792136 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "HYPO-ALLERGENIC PLASTIC TAPE". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
October 22, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Adhesive, Closure, Skin
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by National Patent Development Corp.

  • K843974 — VARIABLE TEMPERATURE CAUTERY DEVICE (February 26, 1985)
  • K832699 — HYDRON WOUND DRESSING FAST SEAT KIT (April 27, 1984)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)
  • K820028 — ZEON COMPOSITE RESIN LIGHT CURE SYS (March 11, 1982)
  • K820006 — ZEON COMPOSITE RESIN SYSTEM (January 22, 1982)
  • K811446 — HYDRON WOUND DRESSING KIT (June 12, 1981)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (July 21, 1980)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)

Other clearances for product code FPX

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K952947 — DELPORE SKIN CLOSURE (July 24, 1995)
  • K952702 — DERMA SEAL (June 28, 1995)
  • K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP (January 12, 1995)
  • K931005 — DUKAL SKIN CLOSURE STRIP (July 14, 1993)
  • K921775 — SPYROFLEX WOUND CLOSURES (May 19, 1992)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)
  • K840945 — SKIN CLOSURE (October 31, 1984)

FDA data resources