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510(k) K943871

AQUAPLAST TIE DOWN DRESSING by Wfr/Aquaplast Corp. — Product Code LZM

K943871 is an FDA 510(k) premarket notification submitted by Wfr/Aquaplast Corp. for the device "AQUAPLAST TIE DOWN DRESSING". The FDA issued a decision of Substantially Equivalent on September 30, 1994. The device falls under product code LZM (Guard, Skin Graft), a Class I device regulated under 21 CFR 878.4014. Wfr/Aquaplast Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1994
Date Received
August 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guard, Skin Graft
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

Other clearances by Wfr/Aquaplast Corp.

  • K120916 — QFIX RADIOTHERAPY CHAIR (June 20, 2012)
  • K060671 — KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS (May 4, 2006)
  • K032156 — ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH (September 2, 2003)
  • K021124 — ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER (July 2, 2002)
  • K973370 — AQUAPLAST PALATAL STENT (December 2, 1997)
  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 1994)
  • K935067 — AQUAPLAST (May 26, 1994)

Other clearances for product code LZM

  • K885136 — GRAFT GUARD (February 6, 1989)

FDA data resources