Home / 510(k) Clearances / K901378

510(k) K901378

TENSOPLUS LITE by Smith & Nephew United, Inc. — Product Code NAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1990
Date Received
March 22, 1990
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

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  • K926508 — INTRASITE GEL (July 13, 1993)
  • K922897 — STRAPPAL (September 15, 1992)

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  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
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