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510(k) K822047

INTERSORB DRY BURN VEST & PANTS by Chesebrough-Pond'S U.S.A. Co. — Product Code NAB

K822047 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "INTERSORB DRY BURN VEST & PANTS". The FDA issued a decision of Substantially Equivalent on July 28, 1982. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1982
Date Received
July 12, 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 Chesebrough-Pond'S U.S.A. Co.

  • K863866 — RESPIRADYNE II(TM) (January 28, 1987)
  • K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING (November 14, 1986)
  • K851383 — BLISTERFILM TRANSPARENT DRESSING (July 5, 1985)
  • K851382 — CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (July 5, 1985)
  • K851539 — CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO (June 12, 1985)
  • K843567 — KANGAROO NASOGASTRIC FEEDING TUBE (February 14, 1985)
  • K844186 — CONTINENT STOMA SYSTEM & ACCESSORIES (January 15, 1985)
  • K845010 — CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (January 15, 1985)
  • K844789 — KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (January 2, 1985)
  • K843128 — FEMALE URINARY INCONTINENCE SYS (January 2, 1985)

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