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510(k) K940755

ISOLYER (4X4, 8PLY) by Isolyer Co. — Product Code NAB

K940755 is an FDA 510(k) premarket notification submitted by Isolyer Co. for the device "ISOLYER (4X4, 8PLY)". The FDA issued a decision of Substantially Equivalent on May 2, 1994. 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
May 2, 1994
Date Received
February 18, 1994
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)
  • 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)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)

FDA data resources