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510(k) K943871

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

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

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  • 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)