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510(k) K921775

SPYROFLEX WOUND CLOSURES by Polymint Industrial Co. , Ltd. — Product Code FPX

K921775 is an FDA 510(k) premarket notification submitted by Polymint Industrial Co. , Ltd. for the device "SPYROFLEX WOUND CLOSURES". The FDA issued a decision of Substantially Equivalent on May 19, 1992. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), 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
SESE (Substantially Equivalent)
Decision Date
May 19, 1992
Date Received
April 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Adhesive, Closure, Skin
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Polymint Industrial Co. , Ltd.

  • K932457 — SPYROGEL WOUND DRESSING (February 9, 1994)
  • K931634 — VARIOUS KITS (November 30, 1993)
  • K911649 — MITRASHEER TRANSPLANT DRESSING (August 7, 1991)
  • K891644 — SAMBORD LATEX PATIENT EXAMINATION GLOVES (June 19, 1989)

Other clearances for product code FPX

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K952947 — DELPORE SKIN CLOSURE (July 24, 1995)
  • K952702 — DERMA SEAL (June 28, 1995)
  • K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP (January 12, 1995)
  • K931005 — DUKAL SKIN CLOSURE STRIP (July 14, 1993)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K842621 — SUTURE STRIP (October 25, 1984)

FDA data resources