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510(k) K001240

SERAGARD INJECTION PATCH by Platinum Services, Inc. — Product Code KGX

K001240 is an FDA 510(k) premarket notification submitted by Platinum Services, Inc. for the device "SERAGARD INJECTION PATCH". The FDA issued a decision of Substantially Equivalent on June 21, 2000. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Platinum Services, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2000
Date Received
April 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Platinum Services, Inc.

  • K001175 — SERAGARD VASCULAR ACCESS PATCH (September 18, 2000)

Other clearances for product code KGX

  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940798 — SHIPPERT PRESSURE BANDAGE (September 28, 1994)

FDA data resources