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510(k) K850076

WOUND DRESSING MODEL ZB-6 by Thermedics, Inc. — Product Code NAD

K850076 is an FDA 510(k) premarket notification submitted by Thermedics, Inc. for the device "WOUND DRESSING MODEL ZB-6". The FDA issued a decision of Substantially Equivalent on April 15, 1985. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Thermedics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1985
Date Received
January 9, 1985
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 Thermedics, Inc.

  • K894131 — DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 (September 26, 1989)
  • K863128 — PERITONEAL DIALYSIS CATHETERS (September 9, 1986)
  • K854966 — ACUTE PERITONEAL DIALYSIS CATHETERS (January 9, 1986)

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)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources