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510(k) K971472

SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA by Technical Products, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1997
Date Received
April 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Technical Products, Inc.

  • K013321 — SILICONE TRACHEAL T-TUBES (June 4, 2002)
  • K973385 — OVAL SHAPES (December 5, 1997)
  • K973166 — DOW CORNING SILASTIC ELASTOMER Q7-4750 (November 21, 1997)
  • K971613 — SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE (May 22, 1997)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)

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