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510(k) K982439

PROXIDERM, MODELS TN 460, TN 90 460, BK 460 by Progressive Surgical Products, Inc. — Product Code MKY

K982439 is an FDA 510(k) premarket notification submitted by Progressive Surgical Products, Inc. for the device "PROXIDERM, MODELS TN 460, TN 90 460, BK 460". The FDA issued a decision of Substantially Equivalent on September 8, 1998. The device falls under product code MKY (System, Skin Closure), a Class I device regulated under 21 CFR 878.4320. Progressive Surgical Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
July 14, 1998
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.

  • K970439 — PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (April 16, 1997)
  • K942425 — PROXIDERM (TENTATIVE) (November 4, 1994)

Other clearances for product code MKY

  • K002315 — WISEBANDS SKIN CLOSURE DEVICE (March 15, 2001)
  • K970439 — PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (April 16, 1997)
  • 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)

FDA data resources