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510(k) K970439

PROXIDERM (D-460,D 90 460,D 180,460, PS 460) by Progressive Surgical Products, Inc. — Product Code MKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1997
Date Received
February 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Skin Closure
Device Class
Class I
Regulation Number
878.4320
Review Panel
SU
Submission Type

Other clearances by Progressive Surgical Products, Inc.

  • K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (September 8, 1998)
  • K942425 — PROXIDERM (TENTATIVE) (November 4, 1994)

Other clearances for product code MKY

  • K002315 — WISEBANDS SKIN CLOSURE DEVICE (March 15, 2001)
  • K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (September 8, 1998)
  • K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEM (January 14, 1997)
  • K942425 — PROXIDERM (TENTATIVE) (November 4, 1994)
  • K942526 — SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (July 19, 1994)