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510(k) K990861

WOUND DRESSING/ABD PAD, MODEL #10810 by Hospital Specialty Co. — Product Code NAD

K990861 is an FDA 510(k) premarket notification submitted by Hospital Specialty Co. for the device "WOUND DRESSING/ABD PAD, MODEL #10810". The FDA issued a decision of Substantially Equivalent on April 12, 1999. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Hospital Specialty Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1999
Date Received
March 16, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Hospital Specialty Co.

  • K941099 — CLEAN-SORB (September 30, 1994)
  • K882094 — GARDS DEODORANT SANITARY NAPKIN (September 22, 1988)
  • K880454 — AT EASE STRESS PAD (June 16, 1988)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)
  • K822242 — SANITARY/OB NAPKINS (September 9, 1982)
  • K822433 — GARDS (UNSCENTED, MENSTRUAL PAD) (August 30, 1982)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)
  • K960815 — DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSIN (April 29, 1996)

FDA data resources