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510(k) K891324

HERMITEX SPONGE by Hermitage Hospital Products, Inc. — Product Code NAB

K891324 is an FDA 510(k) premarket notification submitted by Hermitage Hospital Products, Inc. for the device "HERMITEX SPONGE". The FDA issued a decision of Substantially Equivalent on April 27, 1989. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Hermitage Hospital Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1989
Date Received
March 13, 1989
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 Hermitage Hospital Products, Inc.

  • K941802 — OR TOWEL (May 3, 1995)
  • K923115 — CLINISORB (November 23, 1992)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)
  • K863737 — SPONGES STERILE TWIN PAKT AND SINGLES (October 14, 1986)
  • K843788 — CUSTOM BURN DRESSING KIT (November 7, 1984)
  • K822987 — DRESSING SPONGE (November 5, 1982)
  • K822623 — LAPAROTOMY SPONGE (October 13, 1982)

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