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510(k) K972081

SUPERSKIN by Medlogic Global Corp. — Product Code NEC

K972081 is an FDA 510(k) premarket notification submitted by Medlogic Global Corp. for the device "SUPERSKIN". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code NEC (Bandage, Liquid, Skin Protectant), a Class I device regulated under 21 CFR 880.5090. Medlogic Global Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
June 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid, Skin Protectant
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Medlogic Global Corp.

  • K083531 — LIQUIBAND ULTIMA, MODEL LB0004 (February 12, 2009)
  • K993556 — LIQUIBAND DENTAL (January 3, 2000)

Other clearances for product code NEC

  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)
  • K861558 — APLICARE SKIN PROTECTANT SWABSTICK (June 4, 1986)

FDA data resources