Home / 510(k) Clearances / K926072

510(k) K926072

K-BAND AND K-CREPE by Parema , Ltd. — Product Code NAB

K926072 is an FDA 510(k) premarket notification submitted by Parema , Ltd. for the device "K-BAND AND K-CREPE". The FDA issued a decision of Substantially Equivalent on March 19, 1993. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1993
Date Received
December 1, 1992
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 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)
  • 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)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)

FDA data resources