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510(k) K810318

PARKE-DAVIS NON-WOVEN SPONGE by Hospital Products Co. — Product Code NAB

K810318 is an FDA 510(k) premarket notification submitted by Hospital Products Co. for the device "PARKE-DAVIS NON-WOVEN SPONGE". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Hospital Products Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1981
Date Received
February 6, 1981
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 Hospital Products Co.

  • K823696 — MICRO Z BLOOD COLLECTING NEEDLES (January 26, 1983)
  • K801602 — DESERET I.V. FILTER (August 27, 1980)
  • K801173 — ANGIO-FLO MONITORING KIT (May 28, 1980)
  • K792386 — NUTRA-PH INSTRUMENT MILK (December 10, 1979)
  • K791350 — POPE AMBULATORY HALO VEST (August 3, 1979)

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