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510(k) K923116

COMBINE II WETPROOF PAD by Hermitage Hospital Products, Inc. — Product Code NAB

K923116 is an FDA 510(k) premarket notification submitted by Hermitage Hospital Products, Inc. for the device "COMBINE II WETPROOF PAD". The FDA issued a decision of Substantially Equivalent on October 6, 1992. 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
October 6, 1992
Date Received
June 25, 1992
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)
  • K891324 — HERMITEX SPONGE (April 27, 1989)
  • 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