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510(k) K922228

2ND SKIN STERILE ADHESIVE STRIP by Spenco Medical Corp. — Product Code KGX

K922228 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "2ND SKIN STERILE ADHESIVE STRIP". The FDA issued a decision of Substantially Equivalent (kit) on December 11, 1992. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 11, 1992
Date Received
May 12, 1992
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 Spenco Medical Corp.

  • K981902 — SPENCO SILICONE GEL SHEET (June 25, 1998)
  • K911550 — 2ND SKIN MOIST BURN PADS WITH ALOE (September 6, 1991)
  • K910927 — SPENCIO SKIN GUARD KIT (June 3, 1991)
  • K896533 — SPENCO BREAST FORMS (December 13, 1989)
  • K894898 — 2ND SKIN NON-STICK MOIST BURN PADS (August 23, 1989)
  • K820906 — SPENCO CRYOPRESS (May 13, 1982)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K791726 — HYDROGEL-PREP (November 20, 1979)
  • K791162 — GELSKIN (September 4, 1979)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • 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)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources