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510(k) K915821

MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES by Kerma Medical Products, Inc. — Product Code NAB

K915821 is an FDA 510(k) premarket notification submitted by Kerma Medical Products, Inc. for the device "MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES". The FDA issued a decision of Substantially Equivalent on May 29, 1992. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Kerma Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1992
Date Received
December 30, 1991
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 Kerma Medical Products, Inc.

  • K931042 — MOORE SECURE CAP (April 13, 1994)
  • K915822 — MULTIPLE DRESSING, STERILE NONADDHERENT PADS (March 26, 1992)
  • K914071 — MULTIPLE BURN DRESSING (December 4, 1991)
  • K914937 — STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES (December 4, 1991)

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