Home / 510(k) Clearances / K780764

510(k) K780764

NON-STERILE FOLDED GAUZE by The Owenby Co. — Product Code NAB

K780764 is an FDA 510(k) premarket notification submitted by The Owenby Co. for the device "NON-STERILE FOLDED GAUZE". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. The Owenby Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1978
Date Received
May 4, 1978
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 The Owenby Co.

  • K801628 — RESTRAINT, PROTECTIVE (August 7, 1980)
  • K801626 — ARM SLING (July 28, 1980)
  • K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS (July 28, 1980)
  • K801627 — COVER, LIMB (July 28, 1980)
  • K801531 — ARM SLING (July 21, 1980)
  • K790210 — STOCKINETTE, TUBULAR UNBLEACHED (February 27, 1979)
  • K780418 — BURN DRESSING PAD (April 10, 1978)
  • K770889 — BURN DRESSING KIT (July 11, 1977)
  • K761069 — P.S.M. BOTIQUE CAP (December 30, 1976)
  • K761068 — P.S.M. BOUFFANT CAP (December 30, 1976)

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