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510(k) K820139

SOF-ROL CAST PADDING by Stan-Pak Ent. — Product Code NAB

K820139 is an FDA 510(k) premarket notification submitted by Stan-Pak Ent. for the device "SOF-ROL CAST PADDING". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Stan-Pak Ent. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

Other clearances by Stan-Pak Ent.

  • K823058 — DOSOMETRIC RELEASE STERILIZATION (December 9, 1982)
  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K820099 — TRACH TAPE (February 23, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820105 — COMBINE PAD OR ABD (February 5, 1982)
  • K820056 — TELFA STRIPS (February 5, 1982)

Other clearances for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • K931610 — OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (June 24, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K926072 — K-BAND AND K-CREPE (March 19, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)
  • K924650 — GAUZE SPONGES (January 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K923115 — CLINISORB (November 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (October 6, 1992)

FDA data resources