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510(k) K932457

SPYROGEL WOUND DRESSING by Polymint Industrial Co. , Ltd. — Product Code KGX

K932457 is an FDA 510(k) premarket notification submitted by Polymint Industrial Co. , Ltd. for the device "SPYROGEL WOUND DRESSING". The FDA issued a decision of SN on February 9, 1994. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Polymint Industrial Co. , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 9, 1994
Date Received
May 21, 1993
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 Polymint Industrial Co. , Ltd.

  • K931634 — VARIOUS KITS (November 30, 1993)
  • K921775 — SPYROFLEX WOUND CLOSURES (May 19, 1992)
  • K911649 — MITRASHEER TRANSPLANT DRESSING (August 7, 1991)
  • K891644 — SAMBORD LATEX PATIENT EXAMINATION GLOVES (June 19, 1989)

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